Pending: 32016D0588

16.4.2016 EN Official Journal of the European Union L 101/25
(1) The application submitted by the supplier Valeo Equipments Electriques Moteur on 3 November 2015 for the approval of the Valeo high efficient alternator with high efficiency diodes, and the application submitted by the supplier Robert Bosch GmbH on 10 June 2015 for the approval of the Bosch efficient alternator with MOS gated diodes (MGD) have been assessed in accordance with Article 12 of Regulation (EC) No 443/2009, Commission Implementing Regulation (EU) No 725/2011(2)and the Technical Guidelines for the preparation of applications for the approval of innovative technologies pursuant to Regulation (EC) No 443/2009.
(2) The information provided in the Valeo and Bosch applications demonstrates that the conditions and the criteria referred to in Article 12 of Regulation (EC) No 443/2009 and in Articles 2 and 4 of Implementing Regulation (EU) No 725/2011 have been met. As a consequence, the Valeo and Bosch efficient alternators should be approved as innovative technologies.
(3) By Implementing Decisions 2013/341/EU(3), 2014/465/EU(4), (EU) 2015/158(5), (EU) 2015/295(6)and (EU) 2015/2280(7)the Commission has approved six applications concerning technologies that contribute to improving the efficiency of alternators. Based on the experience gained from the assessment of those applications as well as the Valeo and Bosch applications, it has been satisfactorily and conclusively demonstrated that a 12 Volt (12 V) alternator with a minimum efficiency ranging from 73,4 % to 74,2 %, depending on the powertrain, and a mass not exceeding the mass of the baseline alternator by more than maximum 3 kg meets the eligibility criteria referred to in Article 12 of Regulation (EC) No 443/2009 and Implementing Regulation (EU) No 725/2011 and provides a reduction in CO2emissions of at least 1 g CO2/km compared to a baseline alternator with an efficiency of 67 %.
(4) It is therefore appropriate to provide manufacturers with the possibility to certify the CO2savings from 12 V efficient alternators that meet those conditions. In order to ensure that only alternators that are compliant with those conditions are proposed for certification, the manufacturer should provide a verification report from an independent verification body confirming the compliance together with the application for certification submitted to the type approval authority.
(5) If the type approval authority finds that the 12 V alternator does not satisfy the conditions for certification, the application for certification of the savings should be rejected.
(6) It is appropriate to approve the testing methodology for determining the CO2savings from 12 V efficient alternators.
(7) In order to determine the CO2savings from a 12 V efficient alternator, it is necessary to establish the baseline technology against which the efficiency of the alternator should be assessed. On the basis of the experience gained, it is appropriate to consider a 12 V alternator with 67 % efficiency as a baseline technology.
(8) The savings from a 12 V efficient alternator may be partially demonstrated on the test referred to in Annex XII to Commission Regulation (EC) No 692/2008(8). It is therefore necessary to ensure that this partial coverage is taken into account in the testing methodology for CO2savings from 12 V efficient alternators.
(9) In order to facilitate a wider deployment of 12 V efficient alternators in new vehicles, a manufacturer should also have the possibility to apply for the certification of the CO2savings from several 12 V efficient alternators by a single certification application. It is however appropriate to ensure that where this possibility is used a mechanism is applied that incentivises the deployment of only those alternators that offer the highest efficiency.
(10) For the purposes of determining the general eco-innovation code to be used in the relevant type approval documents in accordance with Annexes I, VIII and IX to Directive 2007/46/EC of the European Parliament and of the Council(9), the individual code to be used for the innovative technology for 12 V efficient alternators should be specified,
(a) it is a component used solely to charge the vehicle battery and to power the electrical system of the vehicle when its combustion engine is running;
(b) the mass of the efficient alternator does not exceed the mass of the baseline alternator of 7 kg by more than 3 kg;
(c) its efficiency is at least:(i)73,8 % for petrol-fuelled vehicles;(ii)73,4 % for petrol turbo-fuelled vehicles;(iii)74,2 % for diesel-fuelled vehicles. (i) 73,8 % for petrol-fuelled vehicles; (ii) 73,4 % for petrol turbo-fuelled vehicles; (iii) 74,2 % for diesel-fuelled vehicles.
(i) 73,8 % for petrol-fuelled vehicles;
(ii) 73,4 % for petrol turbo-fuelled vehicles;
(iii) 74,2 % for diesel-fuelled vehicles.
(i) 73,8 % for petrol-fuelled vehicles;
(ii) 73,4 % for petrol turbo-fuelled vehicles;
(iii) 74,2 % for diesel-fuelled vehicles.
(1) the testing conditions;
(2) the test equipment;
(3) the determination of the efficiency of the efficient alternator and the baseline alternator;
(4) the calculation of the CO2savings;
(5) the calculation of the statistical error.
— CO2savings [g CO2/km]
CO2 — Carbon dioxide
CF — Conversion factor (l/100 km) — (g CO2/km) [g CO2/l] as defined in Table 3
h — Frequency as defined in Table 1
I — Current intensity at which the measurement shall be carried out [A]
m — Number of measurements of the sample
M — Torque [Nm]
n — Rotational frequency [min– 1] as defined in Table 1
P — Power [W]
— Standard deviation of the eco-innovative alternator efficiency [%]
— Standard deviation of the eco-innovative alternator efficiency mean [%]
— Standard deviation of the total CO2savings [g CO2/km]
U — Test voltage at which the measurement shall be carried out [V]
v — Mean driving speed of the New European Driving Cycle (NEDC) [km/h]
VPe — Consumption of effective power [l/kWh] as defined in Table 2
— Sensitivity of calculated CO2savings related to the efficiency of the eco-innovative alternator
Δ — Difference
η — Baseline alternator efficiency [%]
ηEI — Efficient alternator efficiency [%]
— Mean of the eco-innovative alternator efficiency at operating point i [%]
EI — Eco-innovative
m — Mechanical
RW — Real-world conditions
TA — Type approval conditions
B — Baseline
Operating pointi Holding time[s] Rotational frequencyni[min– 1] Frequencyhi
1 1 200 1 800 0,25
2 1 200 3 000 0,40
3 600 6 000 0,25
4 300 10 000 0,10
PRW : Power requirement under ‘real-world’ conditions [W], which is 750 W
PTA : Power requirement under type-approval conditions [W], which is 350 W
ηB : Efficiency of the baseline alternator [%], which is 67 %
v : Mean driving speed of the NEDC [km/h], which is 33,58 km/h
VPe : Is the consumption of effective power specified in the following Table 2Table 2Consumption of effective powerType of engineConsumption of effective power (VPe)[l/kWh]Petrol0,264Petrol Turbo0,280Diesel0,220 Type of engine Consumption of effective power (VPe)[l/kWh] Petrol 0,264 Petrol Turbo 0,280 Diesel 0,220
Type of engine Consumption of effective power (VPe)[l/kWh]
Petrol 0,264
Petrol Turbo 0,280
Diesel 0,220
CF : Is the factor specified in the following Table 3Table 3Fuel conversion factorType of fuelConversion factor (l/100 km) — (g CO2/km) (CF)[g CO2/l]Petrol2 330Diesel2 640 Type of fuel Conversion factor (l/100 km) — (g CO2/km) (CF)[g CO2/l] Petrol 2 330 Diesel 2 640
Type of fuel Conversion factor (l/100 km) — (g CO2/km) (CF)[g CO2/l]
Petrol 2 330
Diesel 2 640
Type of engine Consumption of effective power (VPe)[l/kWh]
Petrol 0,264
Petrol Turbo 0,280
Diesel 0,220
Type of fuel Conversion factor (l/100 km) — (g CO2/km) (CF)[g CO2/l]
Petrol 2 330
Diesel 2 640
MT : Minimum threshold [g CO2/km], which is 1 g CO2/km
— Model and mass of the tested alternators
— Description of the bench
— Test results (measured values)
— Calculated results and corresponding formulae
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 443/2009 of the European Parliament and of the Council of 23 April 2009 setting emissions performance standards for new passenger cars as part of the Community’s integrated approach to reduce CO2emissions from light-duty vehicles(1), and in particular Article 12(4) thereof,
(1) The application submitted by the supplier Valeo Equipments Electriques Moteur on 3 November 2015 for the approval of the Valeo high efficient alternator with high efficiency diodes, and the application submitted by the supplier Robert Bosch GmbH on 10 June 2015 for the approval of the Bosch efficient alternator with MOS gated diodes (MGD) have been assessed in accordance with Article 12 of Regulation (EC) No 443/2009, Commission Implementing Regulation (EU) No 725/2011(2)and the Technical Guidelines for the preparation of applications for the approval of innovative technologies pursuant to Regulation (EC) No 443/2009.
(2) The information provided in the Valeo and Bosch applications demonstrates that the conditions and the criteria referred to in Article 12 of Regulation (EC) No 443/2009 and in Articles 2 and 4 of Implementing Regulation (EU) No 725/2011 have been met. As a consequence, the Valeo and Bosch efficient alternators should be approved as innovative technologies.
(3) By Implementing Decisions 2013/341/EU(3), 2014/465/EU(4), (EU) 2015/158(5), (EU) 2015/295(6)and (EU) 2015/2280(7)the Commission has approved six applications concerning technologies that contribute to improving the efficiency of alternators. Based on the experience gained from the assessment of those applications as well as the Valeo and Bosch applications, it has been satisfactorily and conclusively demonstrated that a 12 Volt (12 V) alternator with a minimum efficiency ranging from 73,4 % to 74,2 %, depending on the powertrain, and a mass not exceeding the mass of the baseline alternator by more than maximum 3 kg meets the eligibility criteria referred to in Article 12 of Regulation (EC) No 443/2009 and Implementing Regulation (EU) No 725/2011 and provides a reduction in CO2emissions of at least 1 g CO2/km compared to a baseline alternator with an efficiency of 67 %.
(4) It is therefore appropriate to provide manufacturers with the possibility to certify the CO2savings from 12 V efficient alternators that meet those conditions. In order to ensure that only alternators that are compliant with those conditions are proposed for certification, the manufacturer should provide a verification report from an independent verification body confirming the compliance together with the application for certification submitted to the type approval authority.
(5) If the type approval authority finds that the 12 V alternator does not satisfy the conditions for certification, the application for certification of the savings should be rejected.
(6) It is appropriate to approve the testing methodology for determining the CO2savings from 12 V efficient alternators.
(7) In order to determine the CO2savings from a 12 V efficient alternator, it is necessary to establish the baseline technology against which the efficiency of the alternator should be assessed. On the basis of the experience gained, it is appropriate to consider a 12 V alternator with 67 % efficiency as a baseline technology.
(8) The savings from a 12 V efficient alternator may be partially demonstrated on the test referred to in Annex XII to Commission Regulation (EC) No 692/2008(8). It is therefore necessary to ensure that this partial coverage is taken into account in the testing methodology for CO2savings from 12 V efficient alternators.
(9) In order to facilitate a wider deployment of 12 V efficient alternators in new vehicles, a manufacturer should also have the possibility to apply for the certification of the CO2savings from several 12 V efficient alternators by a single certification application. It is however appropriate to ensure that where this possibility is used a mechanism is applied that incentivises the deployment of only those alternators that offer the highest efficiency.
(10) For the purposes of determining the general eco-innovation code to be used in the relevant type approval documents in accordance with Annexes I, VIII and IX to Directive 2007/46/EC of the European Parliament and of the Council(9), the individual code to be used for the innovative technology for 12 V efficient alternators should be specified,
HAS ADOPTED THIS DECISION:

Approval
Article 1
The technology used in the Valeo high efficient alternator with high efficiency diodes and in the Bosch efficient alternator with MOS gated diodes is approved as an innovative technology within the meaning of Article 12 of Regulation (EC) No 443/2009.

Application for certification of CO2savings
Article 2
1. The manufacturer may apply for certification of the CO2savings from one or several 12 Volt (V) efficient alternators intended for use in M1vehicles, provided that it complies with the following conditions:
(a)
it is a component used solely to charge the vehicle battery and to power the electrical system of the vehicle when its combustion engine is running;
(b)
the mass of the efficient alternator does not exceed the mass of the baseline alternator of 7 kg by more than 3 kg;
(c)
its efficiency is at least:
(i)
73,8 % for petrol-fuelled vehicles;
(ii)
73,4 % for petrol turbo-fuelled vehicles;
(iii)
74,2 % for diesel-fuelled vehicles.
2. An application for the certification of the savings from one or several efficient alternators shall be accompanied by an independent verification report certifying that the alternator or alternators comply with the conditions set out in paragraph 1.
3. The type approval authority shall reject the application for certification if it finds that the alternator or alternators do not comply with the conditions set out in paragraph 1.

Certification of CO2savings
Article 3
1. The reduction in CO2emissions from the use of an efficient alternator referred to in Article 2(1) shall be determined using the methodology set out in the Annex.
2. Where a manufacturer applies for the certification of the CO2savings from more than one efficient alternator referred to in Article 2(1) in relation to one vehicle version, the type approval authority shall determine which of the alternators tested delivers the lowest CO2savings, and record the lowest value in the relevant type approval documentation. That value shall be indicated in the certificate of conformity in accordance with Article 11(2) of Implementing Regulation (EU) No 725/2011.

Eco-innovation code
Article 4
The eco-innovation code No 17 shall be entered into the type approval documentation where reference is made to this Decision in accordance with Article 11(1) of Implementing Regulation (EU) No 725/2011.

Entry into force
Article 5
This Decision shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 443/2009 of the European Parliament and of the Council of 23 April 2009 setting emissions performance standards for new passenger cars as part of the Community’s integrated approach to reduce CO2emissions from light-duty vehicles(1), and in particular Article 12(4) thereof,
(1) The application submitted by the supplier Valeo Equipments Electriques Moteur on 3 November 2015 for the approval of the Valeo high efficient alternator with high efficiency diodes, and the application submitted by the supplier Robert Bosch GmbH on 10 June 2015 for the approval of the Bosch efficient alternator with MOS gated diodes (MGD) have been assessed in accordance with Article 12 of Regulation (EC) No 443/2009, Commission Implementing Regulation (EU) No 725/2011(2)and the Technical Guidelines for the preparation of applications for the approval of innovative technologies pursuant to Regulation (EC) No 443/2009.
(2) The information provided in the Valeo and Bosch applications demonstrates that the conditions and the criteria referred to in Article 12 of Regulation (EC) No 443/2009 and in Articles 2 and 4 of Implementing Regulation (EU) No 725/2011 have been met. As a consequence, the Valeo and Bosch efficient alternators should be approved as innovative technologies.
(3) By Implementing Decisions 2013/341/EU(3), 2014/465/EU(4), (EU) 2015/158(5), (EU) 2015/295(6)and (EU) 2015/2280(7)the Commission has approved six applications concerning technologies that contribute to improving the efficiency of alternators. Based on the experience gained from the assessment of those applications as well as the Valeo and Bosch applications, it has been satisfactorily and conclusively demonstrated that a 12 Volt (12 V) alternator with a minimum efficiency ranging from 73,4 % to 74,2 %, depending on the powertrain, and a mass not exceeding the mass of the baseline alternator by more than maximum 3 kg meets the eligibility criteria referred to in Article 12 of Regulation (EC) No 443/2009 and Implementing Regulation (EU) No 725/2011 and provides a reduction in CO2emissions of at least 1 g CO2/km compared to a baseline alternator with an efficiency of 67 %.
(4) It is therefore appropriate to provide manufacturers with the possibility to certify the CO2savings from 12 V efficient alternators that meet those conditions. In order to ensure that only alternators that are compliant with those conditions are proposed for certification, the manufacturer should provide a verification report from an independent verification body confirming the compliance together with the application for certification submitted to the type approval authority.
(5) If the type approval authority finds that the 12 V alternator does not satisfy the conditions for certification, the application for certification of the savings should be rejected.
(6) It is appropriate to approve the testing methodology for determining the CO2savings from 12 V efficient alternators.
(7) In order to determine the CO2savings from a 12 V efficient alternator, it is necessary to establish the baseline technology against which the efficiency of the alternator should be assessed. On the basis of the experience gained, it is appropriate to consider a 12 V alternator with 67 % efficiency as a baseline technology.
(8) The savings from a 12 V efficient alternator may be partially demonstrated on the test referred to in Annex XII to Commission Regulation (EC) No 692/2008(8). It is therefore necessary to ensure that this partial coverage is taken into account in the testing methodology for CO2savings from 12 V efficient alternators.
(9) In order to facilitate a wider deployment of 12 V efficient alternators in new vehicles, a manufacturer should also have the possibility to apply for the certification of the CO2savings from several 12 V efficient alternators by a single certification application. It is however appropriate to ensure that where this possibility is used a mechanism is applied that incentivises the deployment of only those alternators that offer the highest efficiency.
(10) For the purposes of determining the general eco-innovation code to be used in the relevant type approval documents in accordance with Annexes I, VIII and IX to Directive 2007/46/EC of the European Parliament and of the Council(9), the individual code to be used for the innovative technology for 12 V efficient alternators should be specified,
HAS ADOPTED THIS DECISION:

Approval

The technology used in the Valeo high efficient alternator with high efficiency diodes and in the Bosch efficient alternator with MOS gated diodes is approved as an innovative technology within the meaning of Article 12 of Regulation (EC) No 443/2009.

Application for certification of CO2savings

1. The manufacturer may apply for certification of the CO2savings from one or several 12 Volt (V) efficient alternators intended for use in M1vehicles, provided that it complies with the following conditions:
(a)
it is a component used solely to charge the vehicle battery and to power the electrical system of the vehicle when its combustion engine is running;
(b)
the mass of the efficient alternator does not exceed the mass of the baseline alternator of 7 kg by more than 3 kg;
(c)
its efficiency is at least:
(i)
73,8 % for petrol-fuelled vehicles;
(ii)
73,4 % for petrol turbo-fuelled vehicles;
(iii)
74,2 % for diesel-fuelled vehicles.
2. An application for the certification of the savings from one or several efficient alternators shall be accompanied by an independent verification report certifying that the alternator or alternators comply with the conditions set out in paragraph 1.
3. The type approval authority shall reject the application for certification if it finds that the alternator or alternators do not comply with the conditions set out in paragraph 1.

Certification of CO2savings

1. The reduction in CO2emissions from the use of an efficient alternator referred to in Article 2(1) shall be determined using the methodology set out in the Annex.
2. Where a manufacturer applies for the certification of the CO2savings from more than one efficient alternator referred to in Article 2(1) in relation to one vehicle version, the type approval authority shall determine which of the alternators tested delivers the lowest CO2savings, and record the lowest value in the relevant type approval documentation. That value shall be indicated in the certificate of conformity in accordance with Article 11(2) of Implementing Regulation (EU) No 725/2011.

Eco-innovation code

The eco-innovation code No 17 shall be entered into the type approval documentation where reference is made to this Decision in accordance with Article 11(1) of Implementing Regulation (EU) No 725/2011.

Entry into force

This Decision shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.

METHODOLOGY TO DETERMINE THE CO2 SAVINGS OF A 12 V EFFICIENT ALTERNATOR

ANNEX1. INTRODUCTIONIn order to determine the CO2savings that can be attributed to the use of an efficient alternator in an M1vehicle, it is necessary to specify the following:

(1) | the testing conditions;
(2) | the test equipment;
(3) | the determination of the efficiency of the efficient alternator and the baseline alternator;
(4) | the calculation of the CO2savings;
(5) | the calculation of the statistical error.
Symbols, parameters and units

Latin symbols

| — | CO2savings [g CO2/km]
CO2 | — | Carbon dioxide
CF | — | Conversion factor (l/100 km) — (g CO2/km) [g CO2/l] as defined in Table 3
h | — | Frequency as defined in Table 1
I | — | Current intensity at which the measurement shall be carried out [A]
m | — | Number of measurements of the sample
M | — | Torque [Nm]
n | — | Rotational frequency [min– 1] as defined in Table 1
P | — | Power [W]
| — | Standard deviation of the eco-innovative alternator efficiency [%]
| — | Standard deviation of the eco-innovative alternator efficiency mean [%]
| — | Standard deviation of the total CO2savings [g CO2/km]
U | — | Test voltage at which the measurement shall be carried out [V]
v | — | Mean driving speed of the New European Driving Cycle (NEDC) [km/h]
VPe | — | Consumption of effective power [l/kWh] as defined in Table 2
| — | Sensitivity of calculated CO2savings related to the efficiency of the eco-innovative alternator
Greek symbols

Δ | — | Difference
η | — | Baseline alternator efficiency [%]
ηEI | — | Efficient alternator efficiency [%]
| — | Mean of the eco-innovative alternator efficiency at operating point i [%]
Subscripts
Index (i) refers to operating point
Index (j) refers to measurement of the sample

EI | — | Eco-innovative
m | — | Mechanical
RW | — | Real-world conditions
TA | — | Type approval conditions
B | — | Baseline2. TEST CONDITIONSThe testing conditions shall fulfil the requirements specified in ISO 8854:2012(1).

Test equipment
The test equipment shall be in accordance with the specifications set out in ISO 8854:2012.
3. MEASUREMENTS AND DETERMINATION OF THE EFFICIENCYThe efficiency of the efficient alternator shall be determined in accordance with ISO 8854:2012, with the exception of the elements specified in the present paragraph.
The measurements shall be conducted at different operating points i, as defined in Table 1. The alternator current intensity is defined as half of the rated current for all operating points. For each speed the voltage and the output current of the alternator are to be kept constant, the voltage at 14,3 V.

Table 1

Operating points

Operating pointi | Holding time[s] | Rotational frequencyni[min– 1] | Frequencyhi
1 | 1 200 | 1 800 | 0,25
2 | 1 200 | 3 000 | 0,40
3 | 600 | 6 000 | 0,25
4 | 300 | 10 000 | 0,10The efficiency shall be calculated in accordance with to Formula 1.

Formula 1

All efficiency measurements are to be performed consecutively at least five (5) times. The average of the measurements at each operating point () has to be calculated.
The efficiency of the eco-innovative alternator (ηEI) shall be calculated in accordance with Formula 2.

Formula 2

The efficient alternator leads to saved mechanical power under real-world conditions (ΔPmRW) and type approval conditions (ΔPmTA) as defined in Formula 3.

Formula 3
ΔPm= ΔPmRW– ΔPmTA
Where the saved mechanical power under real-world conditions (ΔPmRW) is calculated in accordance with Formula 4 and the saved mechanical power under type-approval conditions (ΔPmTA) in accordance with Formula 5.

Formula 4

Formula 5

where

PRW | : | Power requirement under ‘real-world’ conditions [W], which is 750 W
PTA | : | Power requirement under type-approval conditions [W], which is 350 W
ηB | : | Efficiency of the baseline alternator [%], which is 67 %
Calculation of the CO2 savings
The CO2savings of the efficient alternator are to be calculated with the following formula.

Formula 6

where

v | : | Mean driving speed of the NEDC [km/h], which is 33,58 km/h
VPe | : | Is the consumption of effective power specified in the following Table 2Table 2Consumption of effective powerType of engineConsumption of effective power (VPe)[l/kWh]Petrol0,264Petrol Turbo0,280Diesel0,220 | Type of engine | Consumption of effective power (VPe)[l/kWh] | Petrol | 0,264 | Petrol Turbo | 0,280 | Diesel | 0,220
Type of engine | Consumption of effective power (VPe)[l/kWh]
Petrol | 0,264
Petrol Turbo | 0,280
Diesel | 0,220
CF | : | Is the factor specified in the following Table 3Table 3Fuel conversion factorType of fuelConversion factor (l/100 km) — (g CO2/km) (CF)[g CO2/l]Petrol2 330Diesel2 640 | Type of fuel | Conversion factor (l/100 km) — (g CO2/km) (CF)[g CO2/l] | Petrol | 2 330 | Diesel | 2 640
Type of fuel | Conversion factor (l/100 km) — (g CO2/km) (CF)[g CO2/l]
Petrol | 2 330
Diesel | 2 640
Calculation of the statistical error
The statistical errors in the results of the testing methodology caused by the measurements are to be quantified. For each operating point the standard deviation is calculated as defined by the following formula:

Formula 7

The standard deviation of the efficiency value of the efficient alternator () is calculated in accordance with formula 8:

Formula 8

The standard deviation of the alternator efficiency () leads to an error in the CO2savings (). That error is calculated in accordance with formula 9:

Formula 9

Statistical Significance
It has to be demonstrated for each type, variant and version of a vehicle fitted with the efficient alternator that the error in the CO2savings calculated in accordance with Formula 9 is not greater than the difference between the total CO2savings and the minimum savings threshold specified in Article 9(1) of Implementing Regulation (EU) No 725/2011 (see Formula 10).

Formula 10

where:

MT | : | Minimum threshold [g CO2/km], which is 1 g CO2/km
Test and evaluation Report
The report shall include:

— | Model and mass of the tested alternators
— | Description of the bench
— | Test results (measured values)
— | Calculated results and corresponding formulae
The efficient alternator to be fitted in vehicles
The type approval authority is to certify the CO2savings based on measurements of the efficient alternator and the baseline alternator using the test methodology set out in this Annex. Where the CO2emission savings are below the threshold specified in Article 9(1), the second subparagraph of Article 11(2) of Implementing Regulation (EU) No 725/2011 shall apply.

(1) ISO 8854:2012 Road vehicles — Alternators with regulators — Test methods and general requirements. Reference number ISO 8854:2012, published on 1 June 2012.

Pending: 32016D0412

19.3.2016 EN Official Journal of the European Union L 74/41
(1) Article 5(1) of Directive 2000/29/EC, in conjunction with point 2.3 of Section I of Part A of Annex IV to that Directive, provides for special requirements concerning the introduction into the Union of ash (FraxinusL.) wood originating in Canada.
(2) Canada has requested the recognition of a combination of procedures that together attain the same phytosanitary robustness as that ensured pursuant to point 2.3 of Section I of Part A of Annex IV of Directive 2000/29/EC.
(3) It appears from the official information submitted by Canada that, through an integrated systems approach applied during wood processing the risk of infestation fromAgrilus planipennisFairmaire is eliminated.
(4) That approach should be complemented by certain requirements for facilities, pre-export inspections and labelling to ensure the elimination of such risk.
(5) Those procedures should therefore be recognized as an alternative option to point 2.3 of Section I of Part A of Annex IV of Directive 2000/29/EC for imports from Canada.
(6) In order to ensure effective controls, as well as an overview of imports of ash wood and of non-compliances related to those imports, requirements should be set out concerning phytosanitary certificates, reporting of importation and notification of non-compliances.
(7) Taking into account the spread of the harmful organismAgrilus planipennisFairmaire in North America, it is appropriate to limit the duration of the derogation to 31 December 2017.
(8) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
(a) the statement ‘In accordance with European Union requirements laid down in Commission Implementing Decision (EU) 2016/412’;
(b) the bundle number(s);
(c) the name of the approved facility(ies) in Canada.
(a) they are less than 3 cm in width (regardless of length) or
(b) if they are greater than 3 cm in width, the total surface area of each individual piece of bark is less than 50 cm2.
(a) it is officially approved by CFIA pursuant to its certification programme concerning the harmful organismAgrilus planipennisFairmaire;
(b) it is registered in a database published on the CFIA website;
(c) it is audited by CFIA, or an agency approved by CFIA, at least once per month and it has been concluded that it complies with the requirements of this Annex;
(d) it uses equipment for the treatment of wood which has been calibrated consistently with the equipment's manual of operation;
(e) it keeps records of its procedures for verification by CFIA or an agency approved by CFIA, including the duration of treatment, temperatures during treatment and the final moisture content for each specific bundle to be exported.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(1), and in particular the first indent of Article 15(1) thereof,
(1) Article 5(1) of Directive 2000/29/EC, in conjunction with point 2.3 of Section I of Part A of Annex IV to that Directive, provides for special requirements concerning the introduction into the Union of ash (FraxinusL.) wood originating in Canada.
(2) Canada has requested the recognition of a combination of procedures that together attain the same phytosanitary robustness as that ensured pursuant to point 2.3 of Section I of Part A of Annex IV of Directive 2000/29/EC.
(3) It appears from the official information submitted by Canada that, through an integrated systems approach applied during wood processing the risk of infestation fromAgrilus planipennisFairmaire is eliminated.
(4) That approach should be complemented by certain requirements for facilities, pre-export inspections and labelling to ensure the elimination of such risk.
(5) Those procedures should therefore be recognized as an alternative option to point 2.3 of Section I of Part A of Annex IV of Directive 2000/29/EC for imports from Canada.
(6) In order to ensure effective controls, as well as an overview of imports of ash wood and of non-compliances related to those imports, requirements should be set out concerning phytosanitary certificates, reporting of importation and notification of non-compliances.
(7) Taking into account the spread of the harmful organismAgrilus planipennisFairmaire in North America, it is appropriate to limit the duration of the derogation to 31 December 2017.
(8) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS DECISION:

Authorisation to provide for derogation
Article 1
By way of derogation from Article 5(1) of Directive 2000/29/EC in conjunction with point 2.3 of Section I of Part A of Annex IV to that Directive, Member States may authorise the introduction into their territory of wood ofFraxinusL. originating or processed in Canada (hereinafter: ‘specified wood’) which, prior to its movement out of Canada, satisfies the conditions set out in the Annex to this Decision.

Phytosanitary certificate
Article 2
1. The specified wood shall be accompanied by a phytosanitary certificate issued in Canada, in accordance with Article 13a(3) and (4) of Directive 2000/29/EC, certifying freedom from harmful organisms after inspection.
2. The phytosanitary certificate shall include under the heading ‘Additional declaration’ the following elements:
(a)
the statement ‘In accordance with European Union requirements laid down in Commission Implementing Decision (EU) 2016/412’;
(b)
the bundle number(s);
(c)
the name of the approved facility(ies) in Canada.

Reporting of importation
Article 3
The Member State of importation shall provide the Commission and the other Member States, by 31 December of each year, with information on the amounts of consignments of specified wood imported during the previous 12 months pursuant to this Decision.

Notification of non-compliance
Article 4
Member States shall notify the Commission and the other Member States of each consignment not complying with this Decision. That notification shall take place no later than three working days after the date of the interception of such a consignment.

Date of expiry
Article 5
This Decision shall expire on 31 December 2017.

Addressees
Article 6
This Decision is addressed to the Member States.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(1), and in particular the first indent of Article 15(1) thereof,
(1) Article 5(1) of Directive 2000/29/EC, in conjunction with point 2.3 of Section I of Part A of Annex IV to that Directive, provides for special requirements concerning the introduction into the Union of ash (FraxinusL.) wood originating in Canada.
(2) Canada has requested the recognition of a combination of procedures that together attain the same phytosanitary robustness as that ensured pursuant to point 2.3 of Section I of Part A of Annex IV of Directive 2000/29/EC.
(3) It appears from the official information submitted by Canada that, through an integrated systems approach applied during wood processing the risk of infestation fromAgrilus planipennisFairmaire is eliminated.
(4) That approach should be complemented by certain requirements for facilities, pre-export inspections and labelling to ensure the elimination of such risk.
(5) Those procedures should therefore be recognized as an alternative option to point 2.3 of Section I of Part A of Annex IV of Directive 2000/29/EC for imports from Canada.
(6) In order to ensure effective controls, as well as an overview of imports of ash wood and of non-compliances related to those imports, requirements should be set out concerning phytosanitary certificates, reporting of importation and notification of non-compliances.
(7) Taking into account the spread of the harmful organismAgrilus planipennisFairmaire in North America, it is appropriate to limit the duration of the derogation to 31 December 2017.
(8) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS DECISION:

Authorisation to provide for derogation

By way of derogation from Article 5(1) of Directive 2000/29/EC in conjunction with point 2.3 of Section I of Part A of Annex IV to that Directive, Member States may authorise the introduction into their territory of wood ofFraxinusL. originating or processed in Canada (hereinafter: ‘specified wood’) which, prior to its movement out of Canada, satisfies the conditions set out in the Annex to this Decision.

Phytosanitary certificate

1. The specified wood shall be accompanied by a phytosanitary certificate issued in Canada, in accordance with Article 13a(3) and (4) of Directive 2000/29/EC, certifying freedom from harmful organisms after inspection.
2. The phytosanitary certificate shall include under the heading ‘Additional declaration’ the following elements:
(a)
the statement ‘In accordance with European Union requirements laid down in Commission Implementing Decision (EU) 2016/412’;
(b)
the bundle number(s);
(c)
the name of the approved facility(ies) in Canada.

Reporting of importation

The Member State of importation shall provide the Commission and the other Member States, by 31 December of each year, with information on the amounts of consignments of specified wood imported during the previous 12 months pursuant to this Decision.

Notification of non-compliance

Member States shall notify the Commission and the other Member States of each consignment not complying with this Decision. That notification shall take place no later than three working days after the date of the interception of such a consignment.

Date of expiry

This Decision shall expire on 31 December 2017.

Addressees

This Decision is addressed to the Member States.

1.   Processing requirements

ANNEXThe processing of the specified wood, as referred to in Article 1 must fulfil all the following requirements:
(a) Debarking
The specified wood is debarked, with the exception of any number of visually separate and clearly distinct small pieces of bark which comply with one of the following requirements:

(a) | they are less than 3 cm in width (regardless of length) or
(b) | if they are greater than 3 cm in width, the total surface area of each individual piece of bark is less than 50 cm2.(b) Sawing
The specified sawn wood is produced from debarked round wood.
(c) Heat treatment
The specified wood is heated through its profile to at least 71 °C for 1 200 minutes in a heat chamber approved by the Canadian Food Inspection Agency (CFIA), or an agency approved by CFIA.
(d) Drying
The specified wood is dried following industrial drying schedules of at least two-week duration, recognised by CFIA.
The final moisture content of the wood shall not exceed 10 % expressed as a percentage of dry matter.
2. Requirements for facilities
The specified wood must be produced, handled or stored in a facility which fulfils all the following requirements:

(a) | it is officially approved by CFIA pursuant to its certification programme concerning the harmful organismAgrilus planipennisFairmaire;
(b) | it is registered in a database published on the CFIA website;
(c) | it is audited by CFIA, or an agency approved by CFIA, at least once per month and it has been concluded that it complies with the requirements of this Annex;
(d) | it uses equipment for the treatment of wood which has been calibrated consistently with the equipment’s manual of operation;
(e) | it keeps records of its procedures for verification by CFIA or an agency approved by CFIA, including the duration of treatment, temperatures during treatment and the final moisture content for each specific bundle to be exported.3. Labelling
Each bundle of the specified wood must visibly display both a bundle number and a label with the words ‘HT-KD’ or ‘Heat Treated-Kiln Dried’. That label must be issued by, or under the supervision of, a designated officer of the approved facility after verifying that the processing requirements set out in point 1 and the requirements for facilities set out in point 2 have been complied with.
4. Pre-export inspections
The specified wood destined for the Union must be inspected by CFIA, or an agency officially approved by CFIA, to verify that it has undergone, before export, all phytosanitary procedures and measures allowing to conclude that it is free from the harmful organismAgrilus planipennisFairmaire.

Pending: 32015D2460

24.12.2015 EN Official Journal of the European Union L 339/52
(1) Avian influenza is an infectious viral disease in birds, including poultry. Infections with avian influenza viruses in domestic poultry cause two main forms of that disease that are distinguished by their virulence. The low pathogenic form generally only causes mild symptoms, while the highly pathogenic form results in very high mortality rates in most poultry species. That disease may have a severe impact on the profitability of poultry farming.
(2) Avian influenza is mainly found in birds, but under certain circumstances infections can also occur in humans even though the risk is generally very low.
(3) In the event of an outbreak of avian influenza, there is a risk that the disease agent might spread to other holdings where poultry or other captive birds are kept. As a result it may spread from one Member State to other Member States or to third countries through trade in live birds or their products.
(4) Council Directive 2005/94/EC(3)sets out certain preventive measures relating to the surveillance and the early detection of avian influenza and the minimum control measures to be applied in the event of an outbreak of that disease in poultry or other captive birds. Article 16 of that Directive provides for the establishment of protection, surveillance and further restricted zones in the event of an outbreak of highly pathogenic avian influenza. In addition, Article 30 of Directive 2005/94/EC provides for certain measures to be applied in the surveillance zones in order to prevent the spread of the disease, including certain restrictions on the movements of poultry, ready-to-lay-poultry, day-old chicks and hatching eggs.
(5) Council Directive 2009/158/EC(4)lays down rules for trade within the Union in poultry and hatching eggs, including the veterinary certificates to be used.
(6) France notified the Commission of outbreaks of highly pathogenic avian influenza of subtype H5 in holdings on its territory where poultry are kept and it immediately took the measures required pursuant to Directive 2005/94/EC, including the establishment of protection and surveillance zones in accordance with Article 16 of that Directive.
(7) Laboratory investigations have shown that the HPAI viruses of the H5N1, H5N2 and H5N9 subtypes detected in France are clearly different from the HPAI H5N1 virus that appeared in the mid-1990s in Asia and which was first detected in Europe in 2005. The HPAI viruses of H5 subtype currently detected in the south-west of France are of European origin.
(8) Commission Implementing Decision (EU) 2015/2239(5)was adopted in order to list, at Union level, the protection and surveillance zones established by France in accordance with Article 16 of Directive 2005/94/EC.
(9) Due to the current epidemiological situation and the risk of further spread of the disease, France has also established a large further restricted zone around the protection and surveillance zones comprising several departments or parts thereof in the south-west of that Member State.
(10) In order to limit the spread of the disease, France should ensure that no consignments of live poultry, ready-to-lay poultry, day-old chicks and hatching eggs are dispatched from the protection, surveillance and further restricted zone to other parts of France, other Member States or to third countries.
(11) Day-old chicks present a negligible risk for the spread of highly pathogenic avian influenza viruses provided that they have hatched from hatching eggs originating from poultry on holdings located in the further restricted zone and outside the protection and surveillance zones and when the hatchery of dispatch can ensure by its logistics and by its biosecurity working conditions that no contact has occurred between these hatching eggs and any other hatching eggs or day-old chicks originating from poultry flocks within the protection or surveillance zones and which are therefore of a different health status.
(12) Hatching eggs pose a very low risk for disease transmission provided they are collected from flocks that are kept in the further restricted zone and which have undergone serological testing with negative results. Another condition is that such hatching eggs and their packaging have to be disinfected before dispatch from the further restricted zone.
(13) Without prejudice to the measures applicable in the protection and surveillance zone, it is therefore appropriate that the competent authority of France may authorise the dispatch of consignments of day-old chicks and hatching eggs from the further restricted zone listed in the Annex to this Decision in accordance with the above requirements and provided that prior agreement of the competent authority of the Member State or third country of destination has been obtained.
(14) The wide extension of the further restricted zone as established by France in accordance with Article 16(4) of Directive 2005/94/EC would impose a prohibition of movements on a large proportion of the susceptible poultry population.
(15) It is also appropriate to mitigate the risk of poultry becoming exposed to avian influenza viruses circulating in the established surveillance zones by swiftly reducing the density of the susceptible poultry population in these zones that are comprised in the further restricted zone, in particular by timely slaughter and delayed restocking of holdings in that zone.
(16) Given the large and unexpected scale of the outbreaks and the correspondingly wide area of the surveillance zones established around each outbreak, it is necessary to quickly reduce the density of the susceptible poultry on holdings at a particular high risk for infection. A systematic clinical examination of the poultry prior to dispatch would considerably slow down that depopulation process and increase the risk of virus spread.
(17) Therefore, it is appropriate to provide that no systematic clinical investigations of poultry on holdings located in the surveillance zones shall be carried out 24 hours prior to dispatch for direct slaughter within the surveillance zone or the further restricted zone, provided that only direct movements of poultry originating from holdings in the surveillance zones are authorised to a designated slaughterhouse located within the surveillance and further restricted zone; and these movements are carried out under stringent biosecurity measures, including a strict separation from poultry originating from the protection zone, and that cleaning and disinfection is carried out accordingly, and that restocking will be significantly delayed.
(18) The Commission has examined the measures to control the disease and the extent of the zones put under restrictions in collaboration with France, and it deems that they are suitable to achieve the set objectives.
(19) The Commission is also satisfied that the borders of the protection and surveillance and further restricted zone, established by the competent authority of France in accordance with Article 16 of Directive 2005/94/EC, are at a sufficient distance to the actual holdings where outbreaks were confirmed.
(20) In order to prevent any unnecessary disturbance to trade within the Union and to avoid unjustified barriers to trade being imposed by third countries, it is necessary to rapidly define the further restricted zone established in France at Union level and to provide that no consignments of live poultry, ready-to-lay poultry, day-old chicks and hatching eggs are dispatched from the protection and surveillance zones and the further restricted zone to other parts of France, to other Member States or to third countries, except under certain authorised derogations.
(21) In view of the scale of the current developments of the disease outbreaks, it is no longer feasible to timely update the list of the areas established as protection and surveillance zones by a Commission Implementing Decision. Therefore, France shall publish these lists on the website of the French authorities which should also be published on the Commission's website for information purposes.
(22) The further restricted zone around the areas of the protection and surveillance zones should be listed in the Annex to this Decision and the duration of that regionalisation fixed.
(23) Given that France is implementing additional measures as laid down in the Implementing Decision (EU) 2015/2239 to prevent the spread of the avian influenza and for reasons of clarity, that Decision should be repealed.
(24) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
(a) France shall publish lists of the protection and surveillance zones established in accordance with Article 16(1) of Directive 2005/94/EC (‘the lists’).
(b) France shall ensure that the lists are kept up-to-date and provide any update immediately to the Commission, to other Member States and to the public.
(a) they are hatched from hatching eggs originating from poultry holdings located outside the protection and surveillance zones;
(b) the hatchery of dispatch can ensure by its logistics and biosecurity working conditions that no contact has occurred between these hatching eggs and any other hatching eggs or day-old-chicks originating from poultry flocks within established protection and surveillance zones and which are therefore of a different health status;
(c) the competent authority of the Member State or third country of destination is given written notification in advance and has agreed to receive the consignments of the day-old chicks and to notify the date of arrival of the consignments at the holding of destination on its territory to the competent authority of France.
(a) without any undue delay as a single trip;
(b) under stringent biosecurity measures including a strict separation from poultry originating from other regions, as well as cleaning and disinfection measures.
ISO Country Code Member State Name (Department number)
FR France Areas comprising the departments of:
DORDOGNE (24)GERS (32)GIRONDE (33)HAUTE-VIENNE (87)HAUTES-PYRÉNÉES (65)LANDES (40)LOT-ET-GARONNE (47)PYRÉNÉES-ATLANTIQUES (64)
Areas comprising parts of the departments of:
CHARENTE (16) the commune of: 16254 PALLUAUD
LOT (46) the communes of 46006460084606146066460724608746098461144611846120461264612746145461524615346164461694617146178461844618646194462004620546209462154621646219462224623446239462414625046257462584625946297463094631646334 ANGLARS-NOZACLES ARQUESCASSAGNESCAZALSCONCORESDEGAGNACFAJOLESFRAYSSINET-LE-GELATGIGNACGINDOUGOUJOUNACGOURDONLACHAPELLE-AUZACLAMOTHE-FENELONLANZACLAVERCANTIERELEOBARDLHERMLOUPIACMARMINIACMASCLATMILHACMONTCLERAMONTGESTYNADAILLAC-DE-ROUGEPAYRACPAYRIGNACPEYRILLESPOMAREDERAMPOUXLE ROCROUFFILHACSAINT-CAPRAISSAINT-CIRQ-MADELONSAINT-CIRQ-SOUILLAGUETSAINT-CLAIRSALVIACSOUILLACTHEDIRACLE VIGAN
CORREZE (19) the communes of: 190151903019047190661907719107191201912419161191821919119195192291923919289 AYENBRIGNAC-LA-PLAINECHARTRIER-FERRIÈRECUBLACESTIVALSLARCHELOUIGNACMANSACPERPEZAC-LE-BLANCSAINT-AULAIRESAINT-CERNIN-DE-LARCHESAINT-CYPRIENSAINT-PANTALÉON-DE-LARCHESAINT-ROBERTYSSANDON
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market(1), and in particular Article 9(4) thereof,
Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market(2), and in particular Article 10(4) thereof,
(1) Avian influenza is an infectious viral disease in birds, including poultry. Infections with avian influenza viruses in domestic poultry cause two main forms of that disease that are distinguished by their virulence. The low pathogenic form generally only causes mild symptoms, while the highly pathogenic form results in very high mortality rates in most poultry species. That disease may have a severe impact on the profitability of poultry farming.
(2) Avian influenza is mainly found in birds, but under certain circumstances infections can also occur in humans even though the risk is generally very low.
(3) In the event of an outbreak of avian influenza, there is a risk that the disease agent might spread to other holdings where poultry or other captive birds are kept. As a result it may spread from one Member State to other Member States or to third countries through trade in live birds or their products.
(4) Council Directive 2005/94/EC(3)sets out certain preventive measures relating to the surveillance and the early detection of avian influenza and the minimum control measures to be applied in the event of an outbreak of that disease in poultry or other captive birds. Article 16 of that Directive provides for the establishment of protection, surveillance and further restricted zones in the event of an outbreak of highly pathogenic avian influenza. In addition, Article 30 of Directive 2005/94/EC provides for certain measures to be applied in the surveillance zones in order to prevent the spread of the disease, including certain restrictions on the movements of poultry, ready-to-lay-poultry, day-old chicks and hatching eggs.
(5) Council Directive 2009/158/EC(4)lays down rules for trade within the Union in poultry and hatching eggs, including the veterinary certificates to be used.
(6) France notified the Commission of outbreaks of highly pathogenic avian influenza of subtype H5 in holdings on its territory where poultry are kept and it immediately took the measures required pursuant to Directive 2005/94/EC, including the establishment of protection and surveillance zones in accordance with Article 16 of that Directive.
(7) Laboratory investigations have shown that the HPAI viruses of the H5N1, H5N2 and H5N9 subtypes detected in France are clearly different from the HPAI H5N1 virus that appeared in the mid-1990s in Asia and which was first detected in Europe in 2005. The HPAI viruses of H5 subtype currently detected in the south-west of France are of European origin.
(8) Commission Implementing Decision (EU) 2015/2239(5)was adopted in order to list, at Union level, the protection and surveillance zones established by France in accordance with Article 16 of Directive 2005/94/EC.
(9) Due to the current epidemiological situation and the risk of further spread of the disease, France has also established a large further restricted zone around the protection and surveillance zones comprising several departments or parts thereof in the south-west of that Member State.
(10) In order to limit the spread of the disease, France should ensure that no consignments of live poultry, ready-to-lay poultry, day-old chicks and hatching eggs are dispatched from the protection, surveillance and further restricted zone to other parts of France, other Member States or to third countries.
(11) Day-old chicks present a negligible risk for the spread of highly pathogenic avian influenza viruses provided that they have hatched from hatching eggs originating from poultry on holdings located in the further restricted zone and outside the protection and surveillance zones and when the hatchery of dispatch can ensure by its logistics and by its biosecurity working conditions that no contact has occurred between these hatching eggs and any other hatching eggs or day-old chicks originating from poultry flocks within the protection or surveillance zones and which are therefore of a different health status.
(12) Hatching eggs pose a very low risk for disease transmission provided they are collected from flocks that are kept in the further restricted zone and which have undergone serological testing with negative results. Another condition is that such hatching eggs and their packaging have to be disinfected before dispatch from the further restricted zone.
(13) Without prejudice to the measures applicable in the protection and surveillance zone, it is therefore appropriate that the competent authority of France may authorise the dispatch of consignments of day-old chicks and hatching eggs from the further restricted zone listed in the Annex to this Decision in accordance with the above requirements and provided that prior agreement of the competent authority of the Member State or third country of destination has been obtained.
(14) The wide extension of the further restricted zone as established by France in accordance with Article 16(4) of Directive 2005/94/EC would impose a prohibition of movements on a large proportion of the susceptible poultry population.
(15) It is also appropriate to mitigate the risk of poultry becoming exposed to avian influenza viruses circulating in the established surveillance zones by swiftly reducing the density of the susceptible poultry population in these zones that are comprised in the further restricted zone, in particular by timely slaughter and delayed restocking of holdings in that zone.
(16) Given the large and unexpected scale of the outbreaks and the correspondingly wide area of the surveillance zones established around each outbreak, it is necessary to quickly reduce the density of the susceptible poultry on holdings at a particular high risk for infection. A systematic clinical examination of the poultry prior to dispatch would considerably slow down that depopulation process and increase the risk of virus spread.
(17) Therefore, it is appropriate to provide that no systematic clinical investigations of poultry on holdings located in the surveillance zones shall be carried out 24 hours prior to dispatch for direct slaughter within the surveillance zone or the further restricted zone, provided that only direct movements of poultry originating from holdings in the surveillance zones are authorised to a designated slaughterhouse located within the surveillance and further restricted zone; and these movements are carried out under stringent biosecurity measures, including a strict separation from poultry originating from the protection zone, and that cleaning and disinfection is carried out accordingly, and that restocking will be significantly delayed.
(18) The Commission has examined the measures to control the disease and the extent of the zones put under restrictions in collaboration with France, and it deems that they are suitable to achieve the set objectives.
(19) The Commission is also satisfied that the borders of the protection and surveillance and further restricted zone, established by the competent authority of France in accordance with Article 16 of Directive 2005/94/EC, are at a sufficient distance to the actual holdings where outbreaks were confirmed.
(20) In order to prevent any unnecessary disturbance to trade within the Union and to avoid unjustified barriers to trade being imposed by third countries, it is necessary to rapidly define the further restricted zone established in France at Union level and to provide that no consignments of live poultry, ready-to-lay poultry, day-old chicks and hatching eggs are dispatched from the protection and surveillance zones and the further restricted zone to other parts of France, to other Member States or to third countries, except under certain authorised derogations.
(21) In view of the scale of the current developments of the disease outbreaks, it is no longer feasible to timely update the list of the areas established as protection and surveillance zones by a Commission Implementing Decision. Therefore, France shall publish these lists on the website of the French authorities which should also be published on the Commission’s website for information purposes.
(22) The further restricted zone around the areas of the protection and surveillance zones should be listed in the Annex to this Decision and the duration of that regionalisation fixed.
(23) Given that France is implementing additional measures as laid down in the Implementing Decision (EU) 2015/2239 to prevent the spread of the avian influenza and for reasons of clarity, that Decision should be repealed.
(24) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS DECISION:

Article 1
1. France shall establish the protection and surveillance zones in accordance with Article 16(1) of Directive 2005/94/EC, and
(a)
France shall publish lists of the protection and surveillance zones established in accordance with Article 16(1) of Directive 2005/94/EC (‘the lists’).
(b)
France shall ensure that the lists are kept up-to-date and provide any update immediately to the Commission, to other Member States and to the public.
2. The Commission shall publish the lists on its website, for information purposes only.

Article 2
1. Without prejudice to the measures to be applied in the protection and surveillance zones in accordance with Article 1 of this Decision, France shall establish a further restricted zone in accordance with Article 16(4) of Directive 2005/94/EC which includes at least the areas listed as further restricted zone in the Annex to this Decision.
2. France shall ensure that no consignments of live poultry, ready-to-lay poultry, day-old chicks and hatching eggs are dispatched from the areas listed in the Annex.
3. By way of derogation from paragraph 2, the competent authority of France may authorise the dispatch of consignments of day-old chicks from the areas listed in the Annex outside the established protection and surveillance zones to holdings located within that Member State or to other Member States or to third countries provided that:
(a)
they are hatched from hatching eggs originating from poultry holdings located outside the protection and surveillance zones;
(b)
the hatchery of dispatch can ensure by its logistics and biosecurity working conditions that no contact has occurred between these hatching eggs and any other hatching eggs or day-old-chicks originating from poultry flocks within established protection and surveillance zones and which are therefore of a different health status;
(c)
the competent authority of the Member State or third country of destination is given written notification in advance and has agreed to receive the consignments of the day-old chicks and to notify the date of arrival of the consignments at the holding of destination on its territory to the competent authority of France.
4. By way of derogation from paragraph 2, the competent authority of France may authorise the dispatch of consignments of hatching eggs from the areas listed in the Annex outside the established protection and surveillance zones to hatcheries located within that Member State, other Member States or third countries provided that they are collected from holdings situated on the day of collection in the further restricted zone listed in the Annex, and on which the poultry have tested negative in a serological survey for avian influenza capable of detecting 5 % prevalence of disease with at least a 95 % level of confidence and traceability is ensured.
5. France shall ensure that the veterinary certificates provided for in Annex IV to Directive 2009/158/EC accompanying the consignments referred to in paragraph 2 of this Article to be dispatched to other Member States include the words:
‘The consignment complies with the animal health conditions laid down in Commission Implementing Decision (EU) 2015/2460(*1).

Article 3
The competent authority of France shall authorise the dispatch of poultry for direct slaughter from the areas in the surveillance zones listed in accordance with paragraph 1 of Article 1 to a designated slaughterhouse located within the surveillance or the further restricted zone provided that such movement is carried out:
(a)
without any undue delay as a single trip;
(b)
under stringent biosecurity measures including a strict separation from poultry originating from other regions, as well as cleaning and disinfection measures.

Article 4
Implementing Decision (EU) 2015/2239 is repealed.

Article 5
This Decision shall apply until 31 March 2016.

Article 6
This Decision is addressed to the French Republic.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market(1), and in particular Article 9(4) thereof,
Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market(2), and in particular Article 10(4) thereof,
(1) Avian influenza is an infectious viral disease in birds, including poultry. Infections with avian influenza viruses in domestic poultry cause two main forms of that disease that are distinguished by their virulence. The low pathogenic form generally only causes mild symptoms, while the highly pathogenic form results in very high mortality rates in most poultry species. That disease may have a severe impact on the profitability of poultry farming.
(2) Avian influenza is mainly found in birds, but under certain circumstances infections can also occur in humans even though the risk is generally very low.
(3) In the event of an outbreak of avian influenza, there is a risk that the disease agent might spread to other holdings where poultry or other captive birds are kept. As a result it may spread from one Member State to other Member States or to third countries through trade in live birds or their products.
(4) Council Directive 2005/94/EC(3)sets out certain preventive measures relating to the surveillance and the early detection of avian influenza and the minimum control measures to be applied in the event of an outbreak of that disease in poultry or other captive birds. Article 16 of that Directive provides for the establishment of protection, surveillance and further restricted zones in the event of an outbreak of highly pathogenic avian influenza. In addition, Article 30 of Directive 2005/94/EC provides for certain measures to be applied in the surveillance zones in order to prevent the spread of the disease, including certain restrictions on the movements of poultry, ready-to-lay-poultry, day-old chicks and hatching eggs.
(5) Council Directive 2009/158/EC(4)lays down rules for trade within the Union in poultry and hatching eggs, including the veterinary certificates to be used.
(6) France notified the Commission of outbreaks of highly pathogenic avian influenza of subtype H5 in holdings on its territory where poultry are kept and it immediately took the measures required pursuant to Directive 2005/94/EC, including the establishment of protection and surveillance zones in accordance with Article 16 of that Directive.
(7) Laboratory investigations have shown that the HPAI viruses of the H5N1, H5N2 and H5N9 subtypes detected in France are clearly different from the HPAI H5N1 virus that appeared in the mid-1990s in Asia and which was first detected in Europe in 2005. The HPAI viruses of H5 subtype currently detected in the south-west of France are of European origin.
(8) Commission Implementing Decision (EU) 2015/2239(5)was adopted in order to list, at Union level, the protection and surveillance zones established by France in accordance with Article 16 of Directive 2005/94/EC.
(9) Due to the current epidemiological situation and the risk of further spread of the disease, France has also established a large further restricted zone around the protection and surveillance zones comprising several departments or parts thereof in the south-west of that Member State.
(10) In order to limit the spread of the disease, France should ensure that no consignments of live poultry, ready-to-lay poultry, day-old chicks and hatching eggs are dispatched from the protection, surveillance and further restricted zone to other parts of France, other Member States or to third countries.
(11) Day-old chicks present a negligible risk for the spread of highly pathogenic avian influenza viruses provided that they have hatched from hatching eggs originating from poultry on holdings located in the further restricted zone and outside the protection and surveillance zones and when the hatchery of dispatch can ensure by its logistics and by its biosecurity working conditions that no contact has occurred between these hatching eggs and any other hatching eggs or day-old chicks originating from poultry flocks within the protection or surveillance zones and which are therefore of a different health status.
(12) Hatching eggs pose a very low risk for disease transmission provided they are collected from flocks that are kept in the further restricted zone and which have undergone serological testing with negative results. Another condition is that such hatching eggs and their packaging have to be disinfected before dispatch from the further restricted zone.
(13) Without prejudice to the measures applicable in the protection and surveillance zone, it is therefore appropriate that the competent authority of France may authorise the dispatch of consignments of day-old chicks and hatching eggs from the further restricted zone listed in the Annex to this Decision in accordance with the above requirements and provided that prior agreement of the competent authority of the Member State or third country of destination has been obtained.
(14) The wide extension of the further restricted zone as established by France in accordance with Article 16(4) of Directive 2005/94/EC would impose a prohibition of movements on a large proportion of the susceptible poultry population.
(15) It is also appropriate to mitigate the risk of poultry becoming exposed to avian influenza viruses circulating in the established surveillance zones by swiftly reducing the density of the susceptible poultry population in these zones that are comprised in the further restricted zone, in particular by timely slaughter and delayed restocking of holdings in that zone.
(16) Given the large and unexpected scale of the outbreaks and the correspondingly wide area of the surveillance zones established around each outbreak, it is necessary to quickly reduce the density of the susceptible poultry on holdings at a particular high risk for infection. A systematic clinical examination of the poultry prior to dispatch would considerably slow down that depopulation process and increase the risk of virus spread.
(17) Therefore, it is appropriate to provide that no systematic clinical investigations of poultry on holdings located in the surveillance zones shall be carried out 24 hours prior to dispatch for direct slaughter within the surveillance zone or the further restricted zone, provided that only direct movements of poultry originating from holdings in the surveillance zones are authorised to a designated slaughterhouse located within the surveillance and further restricted zone; and these movements are carried out under stringent biosecurity measures, including a strict separation from poultry originating from the protection zone, and that cleaning and disinfection is carried out accordingly, and that restocking will be significantly delayed.
(18) The Commission has examined the measures to control the disease and the extent of the zones put under restrictions in collaboration with France, and it deems that they are suitable to achieve the set objectives.
(19) The Commission is also satisfied that the borders of the protection and surveillance and further restricted zone, established by the competent authority of France in accordance with Article 16 of Directive 2005/94/EC, are at a sufficient distance to the actual holdings where outbreaks were confirmed.
(20) In order to prevent any unnecessary disturbance to trade within the Union and to avoid unjustified barriers to trade being imposed by third countries, it is necessary to rapidly define the further restricted zone established in France at Union level and to provide that no consignments of live poultry, ready-to-lay poultry, day-old chicks and hatching eggs are dispatched from the protection and surveillance zones and the further restricted zone to other parts of France, to other Member States or to third countries, except under certain authorised derogations.
(21) In view of the scale of the current developments of the disease outbreaks, it is no longer feasible to timely update the list of the areas established as protection and surveillance zones by a Commission Implementing Decision. Therefore, France shall publish these lists on the website of the French authorities which should also be published on the Commission’s website for information purposes.
(22) The further restricted zone around the areas of the protection and surveillance zones should be listed in the Annex to this Decision and the duration of that regionalisation fixed.
(23) Given that France is implementing additional measures as laid down in the Implementing Decision (EU) 2015/2239 to prevent the spread of the avian influenza and for reasons of clarity, that Decision should be repealed.
(24) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS DECISION:
1. France shall establish the protection and surveillance zones in accordance with Article 16(1) of Directive 2005/94/EC, and
(a)
France shall publish lists of the protection and surveillance zones established in accordance with Article 16(1) of Directive 2005/94/EC (‘the lists’).
(b)
France shall ensure that the lists are kept up-to-date and provide any update immediately to the Commission, to other Member States and to the public.
2. The Commission shall publish the lists on its website, for information purposes only.
1. Without prejudice to the measures to be applied in the protection and surveillance zones in accordance with Article 1 of this Decision, France shall establish a further restricted zone in accordance with Article 16(4) of Directive 2005/94/EC which includes at least the areas listed as further restricted zone in the Annex to this Decision.
2. France shall ensure that no consignments of live poultry, ready-to-lay poultry, day-old chicks and hatching eggs are dispatched from the areas listed in the Annex.
3. By way of derogation from paragraph 2, the competent authority of France may authorise the dispatch of consignments of day-old chicks from the areas listed in the Annex outside the established protection and surveillance zones to holdings located within that Member State or to other Member States or to third countries provided that:
(a)
they are hatched from hatching eggs originating from poultry holdings located outside the protection and surveillance zones;
(b)
the hatchery of dispatch can ensure by its logistics and biosecurity working conditions that no contact has occurred between these hatching eggs and any other hatching eggs or day-old-chicks originating from poultry flocks within established protection and surveillance zones and which are therefore of a different health status;
(c)
the competent authority of the Member State or third country of destination is given written notification in advance and has agreed to receive the consignments of the day-old chicks and to notify the date of arrival of the consignments at the holding of destination on its territory to the competent authority of France.
4. By way of derogation from paragraph 2, the competent authority of France may authorise the dispatch of consignments of hatching eggs from the areas listed in the Annex outside the established protection and surveillance zones to hatcheries located within that Member State, other Member States or third countries provided that they are collected from holdings situated on the day of collection in the further restricted zone listed in the Annex, and on which the poultry have tested negative in a serological survey for avian influenza capable of detecting 5 % prevalence of disease with at least a 95 % level of confidence and traceability is ensured.
5. France shall ensure that the veterinary certificates provided for in Annex IV to Directive 2009/158/EC accompanying the consignments referred to in paragraph 2 of this Article to be dispatched to other Member States include the words:
‘The consignment complies with the animal health conditions laid down in Commission Implementing Decision (EU) 2015/2460(*1).
The competent authority of France shall authorise the dispatch of poultry for direct slaughter from the areas in the surveillance zones listed in accordance with paragraph 1 of Article 1 to a designated slaughterhouse located within the surveillance or the further restricted zone provided that such movement is carried out:
(a)
without any undue delay as a single trip;
(b)
under stringent biosecurity measures including a strict separation from poultry originating from other regions, as well as cleaning and disinfection measures.
Implementing Decision (EU) 2015/2239 is repealed.
This Decision shall apply until 31 March 2016.
This Decision is addressed to the French Republic.
ANNEXFurther restricted zone as referred to in Article 1:

ISO Country Code | Member State | Name (Department number) | |
FR | France | Areas comprising the departments of:
| | DORDOGNE (24)GERS (32)GIRONDE (33)HAUTE-VIENNE (87)HAUTES-PYRÉNÉES (65)LANDES (40)LOT-ET-GARONNE (47)PYRÉNÉES-ATLANTIQUES (64) | |
| | Areas comprising parts of the departments of: | |
| | CHARENTE (16) the commune of: | 16254 | PALLUAUD
| | LOT (46) the communes of | 46006460084606146066460724608746098461144611846120461264612746145461524615346164461694617146178461844618646194462004620546209462154621646219462224623446239462414625046257462584625946297463094631646334 | ANGLARS-NOZACLES ARQUESCASSAGNESCAZALSCONCORESDEGAGNACFAJOLESFRAYSSINET-LE-GELATGIGNACGINDOUGOUJOUNACGOURDONLACHAPELLE-AUZACLAMOTHE-FENELONLANZACLAVERCANTIERELEOBARDLHERMLOUPIACMARMINIACMASCLATMILHACMONTCLERAMONTGESTYNADAILLAC-DE-ROUGEPAYRACPAYRIGNACPEYRILLESPOMAREDERAMPOUXLE ROCROUFFILHACSAINT-CAPRAISSAINT-CIRQ-MADELONSAINT-CIRQ-SOUILLAGUETSAINT-CLAIRSALVIACSOUILLACTHEDIRACLE VIGAN
| | CORREZE (19) the communes of: | 190151903019047190661907719107191201912419161191821919119195192291923919289 | AYENBRIGNAC-LA-PLAINECHARTRIER-FERRIÈRECUBLACESTIVALSLARCHELOUIGNACMANSACPERPEZAC-LE-BLANCSAINT-AULAIRESAINT-CERNIN-DE-LARCHESAINT-CYPRIENSAINT-PANTALÉON-DE-LARCHESAINT-ROBERTYSSANDON

Pending: 32015D2430

22.12.2015 EN Official Journal of the European Union L 334/18
(1) On 27 December 2001, the Council adopted Common Position 2001/931/CFSP(1).
(2) On 31 July 2015, the Council adopted Decision (CFSP) 2015/1334(2)updating the list of persons, groups and entities subject to Articles 2, 3 and 4 of Common Position 2001/931/CFSP (‘the list’).
(3) In accordance with Article 1(6) of Common Position 2001/931/CFSP, it is necessary to review at regular intervals the names of persons, groups and entities on the list to ensure that there are grounds for keeping them thereon.
(4) This Decision sets out the result of the review that the Council has carried out in respect of persons, groups and entities to which Articles 2, 3 and 4 of Common Position 2001/931/CFSP apply.
(5) The Council has verified that competent authorities as referred to in Article 1(4) of Common Position 2001/931/CFSP have taken decisions with regard to all persons, groups and entities on the list to the effect that they have been involved in terrorist acts within the meaning of Article 1(2) and (3) of Common Position 2001/931/CFSP. The Council has also concluded that the persons, groups and entities to which Articles 2, 3 and 4 of Common Position 2001/931/CFSP apply should continue to be subject to the specific restrictive measures provided for therein.
(6) The list should be updated accordingly and Decision (CFSP) 2015/1334 should be repealed,
1. ABDOLLAHI Hamed (a.k.a Mustafa Abdullahi), born 11 August 1960 in Iran. Passport: D9004878.
2. AL-NASSER, Abdelkarim Hussein Mohamed, born in Al Ihsa (Saudi Arabia), citizen of Saudi Arabia.
3. AL YACOUB, Ibrahim Salih Mohammed, born 16 October 1966 in Tarut (Saudi Arabia), citizen of Saudi Arabia.
4. ARBABSIAR Manssor (a.k.a. Mansour Arbabsiar), born 6 or 15 March 1955 in Iran. Iranian and US national. Passport: C2002515 (Iran); Passport: 477845448 (USA). National ID No: 07442833, expiry date 15 March 2016 (USA driving licence).
5. BOUYERI, Mohammed (a.k.a. Abu ZUBAIR, a.k.a. SOBIAR, a.k.a. Abu ZOUBAIR), born 8 March 1978 in Amsterdam (The Netherlands) — member of the ‘Hofstadgroep’.
6. IZZ-AL-DIN, Hasan (a.k.a GARBAYA, Ahmed, a.k.a. SA-ID, a.k.a. SALWWAN, Samir), Lebanon, born 1963 in Lebanon, citizen of Lebanon.
7. MOHAMMED, Khalid Shaikh (a.k.a. ALI, Salem, a.k.a. BIN KHALID, Fahd Bin Adballah, a.k.a. HENIN, Ashraf Refaat Nabith, a.k.a. WADOOD, Khalid Adbul), born 14 April 1965 or 1 March 1964 in Pakistan, passport No 488555.
8. SHAHLAI Abdul Reza (a.k.a Abdol Reza Shala'i, a.k.a. Abd-al Reza Shalai, a.k.a. Abdorreza Shahlai, a.k.a. Abdolreza Shahla'i, a.k.a. Abdul-Reza Shahlaee, a.k.a.Hajj Yusef, a.k.a. Haji Yusif, a.k.a.Hajji Yasir, a.k.a.Hajji Yusif, a.k.a.Yusuf Abu-al-Karkh), born circa 1957 in Iran. Addresses: (1) Kermanshah, Iran; (2) Mehran Military Base, Ilam Province, Iran.
9. SHAKURI Ali Gholam, born circa 1965 in Tehran, Iran.
10. SOLEIMANI Qasem (a.k.a Ghasem Soleymani, a.k.a Qasmi Sulayman, a.k.a Qasem Soleymani, a.k.a Qasem Solaimani, a.k.a Qasem Salimani, a.k.a Qasem Solemani, a.k.a Qasem Sulaimani, a.k.a Qasem Sulemani), born 11 March 1957 in Iran. Iranian national. Passport: 008827 (Iran Diplomatic), issued 1999. Title: Major General.
1. ‘Abu Nidal Organisation’ — ‘ANO’ (a.k.a. ‘Fatah Revolutionary Council’, a.k.a. ‘Arab Revolutionary Brigades’, a.k.a. ‘Black September’, a.k.a. ‘Revolutionary Organisation of Socialist Muslims’.
2. ‘Al-Aqsa Martyrs’ Brigade.
3. Al-Aqsa e.V.
4. ‘Babbar Khalsa’.
5. ‘Communist Party of the Philippines’, including ‘New People's Army’ — ‘NPA’, Philippines.
6. ‘Gama'a al-Islamiyya’ (a.k.a. ‘Al-Gama'a al-Islamiyya’) (‘Islamic Group’ — ‘IG’).
7. ‘İslami Büyük Doğu Akıncılar Cephesi’ — ‘IBDA-C’ (‘Great Islamic Eastern Warriors Front’.
8. ‘Hamas’, including ‘Hamas-Izz al-Din al-Qassem’.
9. ‘Hizballah Military Wing’ (a.k.a. ‘Hezbollah Military Wing’, a.k.a. ‘Hizbullah Military Wing’, a.k.a. ‘Hizbollah Military Wing’, a.k.a. ‘Hezballah Military Wing’, a.k.a. ‘Hisbollah Military Wing’, a.k.a. ‘Hizbu'llah Military Wing’ a.k.a. ‘Hizb Allah Military Wing’, a.k.a. ‘Jihad Council’ (and all units reporting to it, including the External Security Organisation)).
10. ‘Hizbul Mujahideen’ — ‘HM’.
11. Hofstadgroep.
12. ‘International Sikh Youth Federation’ — ‘ISYF’.
13. ‘Khalistan Zindabad Force’ — ‘KZF’.
14. ‘Kurdistan Workers' Party’ — ‘PKK’, (a.k.a. ‘KADEK’, a.k.a. ‘KONGRA-GEL’).
15. ‘Liberation Tigers of Tamil Eelam’ — ‘LTTE’.
16. ‘Ejército de Liberación Nacional’ (‘National Liberation Army’).
17. ‘Palestinian Islamic Jihad’ — ‘PIJ’.
18. ‘Popular Front for the Liberation of Palestine’ — ‘PFLP’.
19. ‘Popular Front for the Liberation of Palestine — General Command’ (a.k.a. ‘PFLP — General Command’).
20. ‘Fuerzas armadas revolucionarias de Colombia’ — ‘FARC’ (‘Revolutionary Armed Forces of Colombia’).
21. ‘Devrimci Halk Kurtuluș Partisi-Cephesi’ — ‘DHKP/C’ (a.k.a. ‘Devrimci Sol’ (‘Revolutionary Left’), a.k.a. ‘Dev Sol’) (‘Revolutionary People's Liberation Army/Front/Party’).
22. ‘Sendero Luminoso’ — ‘SL’ (‘Shining Path’).
23. ‘Teyrbazen Azadiya Kurdistan’ — ‘TAK’ (a.k.a. ‘Kurdistan Freedom Falcons’, a.k.a. ‘Kurdistan Freedom Hawks’).
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union, and in particular Article 29 thereof,
Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
(1) On 27 December 2001, the Council adopted Common Position 2001/931/CFSP(1).
(2) On 31 July 2015, the Council adopted Decision (CFSP) 2015/1334(2)updating the list of persons, groups and entities subject to Articles 2, 3 and 4 of Common Position 2001/931/CFSP (‘the list’).
(3) In accordance with Article 1(6) of Common Position 2001/931/CFSP, it is necessary to review at regular intervals the names of persons, groups and entities on the list to ensure that there are grounds for keeping them thereon.
(4) This Decision sets out the result of the review that the Council has carried out in respect of persons, groups and entities to which Articles 2, 3 and 4 of Common Position 2001/931/CFSP apply.
(5) The Council has verified that competent authorities as referred to in Article 1(4) of Common Position 2001/931/CFSP have taken decisions with regard to all persons, groups and entities on the list to the effect that they have been involved in terrorist acts within the meaning of Article 1(2) and (3) of Common Position 2001/931/CFSP. The Council has also concluded that the persons, groups and entities to which Articles 2, 3 and 4 of Common Position 2001/931/CFSP apply should continue to be subject to the specific restrictive measures provided for therein.
(6) The list should be updated accordingly and Decision (CFSP) 2015/1334 should be repealed,
HAS ADOPTED THIS DECISION:

Article 1
The list of persons, groups and entities to which Articles 2, 3 and 4 of Common Position 2001/931/CFSP apply is set out in the Annex to this Decision.

Article 2
Decision (CFSP) 2015/1334 is hereby repealed.

Article 3
This Decision shall enter into force on the day following that of its publication in theOfficial Journal of the European Union.

THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union, and in particular Article 29 thereof,
Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
(1) On 27 December 2001, the Council adopted Common Position 2001/931/CFSP(1).
(2) On 31 July 2015, the Council adopted Decision (CFSP) 2015/1334(2)updating the list of persons, groups and entities subject to Articles 2, 3 and 4 of Common Position 2001/931/CFSP (‘the list’).
(3) In accordance with Article 1(6) of Common Position 2001/931/CFSP, it is necessary to review at regular intervals the names of persons, groups and entities on the list to ensure that there are grounds for keeping them thereon.
(4) This Decision sets out the result of the review that the Council has carried out in respect of persons, groups and entities to which Articles 2, 3 and 4 of Common Position 2001/931/CFSP apply.
(5) The Council has verified that competent authorities as referred to in Article 1(4) of Common Position 2001/931/CFSP have taken decisions with regard to all persons, groups and entities on the list to the effect that they have been involved in terrorist acts within the meaning of Article 1(2) and (3) of Common Position 2001/931/CFSP. The Council has also concluded that the persons, groups and entities to which Articles 2, 3 and 4 of Common Position 2001/931/CFSP apply should continue to be subject to the specific restrictive measures provided for therein.
(6) The list should be updated accordingly and Decision (CFSP) 2015/1334 should be repealed,
HAS ADOPTED THIS DECISION:
The list of persons, groups and entities to which Articles 2, 3 and 4 of Common Position 2001/931/CFSP apply is set out in the Annex to this Decision.
Decision (CFSP) 2015/1334 is hereby repealed.
This Decision shall enter into force on the day following that of its publication in theOfficial Journal of the European Union.

LIST OF PERSONS, GROUPS AND ENTITIES REFERRED TO IN ARTICLE 1

ANNEXI. PERSONS
1. | ABDOLLAHI Hamed (a.k.a Mustafa Abdullahi), born 11 August 1960 in Iran. Passport: D9004878.
2. | AL-NASSER, Abdelkarim Hussein Mohamed, born in Al Ihsa (Saudi Arabia), citizen of Saudi Arabia.
3. | AL YACOUB, Ibrahim Salih Mohammed, born 16 October 1966 in Tarut (Saudi Arabia), citizen of Saudi Arabia.
4. | ARBABSIAR Manssor (a.k.a. Mansour Arbabsiar), born 6 or 15 March 1955 in Iran. Iranian and US national. Passport: C2002515 (Iran); Passport: 477845448 (USA). National ID No: 07442833, expiry date 15 March 2016 (USA driving licence).
5. | BOUYERI, Mohammed (a.k.a. Abu ZUBAIR, a.k.a. SOBIAR, a.k.a. Abu ZOUBAIR), born 8 March 1978 in Amsterdam (The Netherlands) — member of the ‘Hofstadgroep’.
6. | IZZ-AL-DIN, Hasan (a.k.a GARBAYA, Ahmed, a.k.a. SA-ID, a.k.a. SALWWAN, Samir), Lebanon, born 1963 in Lebanon, citizen of Lebanon.
7. | MOHAMMED, Khalid Shaikh (a.k.a. ALI, Salem, a.k.a. BIN KHALID, Fahd Bin Adballah, a.k.a. HENIN, Ashraf Refaat Nabith, a.k.a. WADOOD, Khalid Adbul), born 14 April 1965 or 1 March 1964 in Pakistan, passport No 488555.
8. | SHAHLAI Abdul Reza (a.k.a Abdol Reza Shala’i, a.k.a. Abd-al Reza Shalai, a.k.a. Abdorreza Shahlai, a.k.a. Abdolreza Shahla’i, a.k.a. Abdul-Reza Shahlaee, a.k.a.Hajj Yusef, a.k.a. Haji Yusif, a.k.a.Hajji Yasir, a.k.a.Hajji Yusif, a.k.a.Yusuf Abu-al-Karkh), born circa 1957 in Iran. Addresses: (1) Kermanshah, Iran; (2) Mehran Military Base, Ilam Province, Iran.
9. | SHAKURI Ali Gholam, born circa 1965 in Tehran, Iran.
10. | SOLEIMANI Qasem (a.k.a Ghasem Soleymani, a.k.a Qasmi Sulayman, a.k.a Qasem Soleymani, a.k.a Qasem Solaimani, a.k.a Qasem Salimani, a.k.a Qasem Solemani, a.k.a Qasem Sulaimani, a.k.a Qasem Sulemani), born 11 March 1957 in Iran. Iranian national. Passport: 008827 (Iran Diplomatic), issued 1999. Title: Major General.II. GROUPS AND ENTITIES
1. | ‘Abu Nidal Organisation’ — ‘ANO’ (a.k.a. ‘Fatah Revolutionary Council’, a.k.a. ‘Arab Revolutionary Brigades’, a.k.a. ‘Black September’, a.k.a. ‘Revolutionary Organisation of Socialist Muslims’.
2. | ‘Al-Aqsa Martyrs’ Brigade.
3. | Al-Aqsa e.V.
4. | ‘Babbar Khalsa’.
5. | ‘Communist Party of the Philippines’, including ‘New People’s Army’ — ‘NPA’, Philippines.
6. | ‘Gama’a al-Islamiyya’ (a.k.a. ‘Al-Gama’a al-Islamiyya’) (‘Islamic Group’ — ‘IG’).
7. | ‘İslami Büyük Doğu Akıncılar Cephesi’ — ‘IBDA-C’ (‘Great Islamic Eastern Warriors Front’.
8. | ‘Hamas’, including ‘Hamas-Izz al-Din al-Qassem’.
9. | ‘Hizballah Military Wing’ (a.k.a. ‘Hezbollah Military Wing’, a.k.a. ‘Hizbullah Military Wing’, a.k.a. ‘Hizbollah Military Wing’, a.k.a. ‘Hezballah Military Wing’, a.k.a. ‘Hisbollah Military Wing’, a.k.a. ‘Hizbu’llah Military Wing’ a.k.a. ‘Hizb Allah Military Wing’, a.k.a. ‘Jihad Council’ (and all units reporting to it, including the External Security Organisation)).
10. | ‘Hizbul Mujahideen’ — ‘HM’.
11. | Hofstadgroep.
12. | ‘International Sikh Youth Federation’ — ‘ISYF’.
13. | ‘Khalistan Zindabad Force’ — ‘KZF’.
14. | ‘Kurdistan Workers’ Party’ — ‘PKK’, (a.k.a. ‘KADEK’, a.k.a. ‘KONGRA-GEL’).
15. | ‘Liberation Tigers of Tamil Eelam’ — ‘LTTE’.
16. | ‘Ejército de Liberación Nacional’ (‘National Liberation Army’).
17. | ‘Palestinian Islamic Jihad’ — ‘PIJ’.
18. | ‘Popular Front for the Liberation of Palestine’ — ‘PFLP’.
19. | ‘Popular Front for the Liberation of Palestine — General Command’ (a.k.a. ‘PFLP — General Command’).
20. | ‘Fuerzas armadas revolucionarias de Colombia’ — ‘FARC’ (‘Revolutionary Armed Forces of Colombia’).
21. | ‘Devrimci Halk Kurtuluș Partisi-Cephesi’ — ‘DHKP/C’ (a.k.a. ‘Devrimci Sol’ (‘Revolutionary Left’), a.k.a. ‘Dev Sol’) (‘Revolutionary People’s Liberation Army/Front/Party’).
22. | ‘Sendero Luminoso’ — ‘SL’ (‘Shining Path’).
23. | ‘Teyrbazen Azadiya Kurdistan’ — ‘TAK’ (a.k.a. ‘Kurdistan Freedom Falcons’, a.k.a. ‘Kurdistan Freedom Hawks’).

Pending: 32015D2099

20.11.2015 EN Official Journal of the European Union L 303/75
(1) Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to products which have a reduced environmental impact during their entire life cycle.
(2) Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.
(3) Commission Decision 2006/799/EC(2)and Commission Decision 2007/64/EC(3)have established the ecological criteria and the related assessment and verification requirements for soil improvers and growing media, respectively, which are valid until 31 December 2015.
(4) In order to better reflect the state of the art of the market for these product groups and take into account the innovation of the last years, it is considered appropriate to merge both product groups into one product group and add mulch to its scope, as it is distinguished as a type of soil improver with particular characteristics and functions.
(5) The revised criteria, as well as the related assessment and verification requirements should be valid for 4 years from the date of adoption of this Decision, taking into account the innovation cycle for this product group. These criteria aim at promoting the recycling of materials, the use of renewable and recycled materials, thus reducing environmental degradation, and decreasing soil and water pollution by means of establishing strict limits on pollutants concentrations in the final product.
(6) Decision 2006/799/EC and Decision 2007/64/EC should therefore be replaced by this Decision.
(7) A transitional period should be allowed for producers whose products have been awarded the EU Ecolabel for soil improvers and growing media on the basis of the criteria set out in Decision 2006/799/EC and Decision 2007/64/EC, respectively, so that they have sufficient time to adapt their products to comply with the revised criteria and requirements.
(8) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,
(1) ‘Growing medium’ means a material used as a substrate for root development, in which plants are grown;
(2) ‘Mineral growing medium’ means a growing medium totally composed by mineral constituents;
(3) ‘Soil improver’ means a material added to soil in situ whose main function is to maintain or improve its physical and/or chemical and/or biological properties, with the exception of liming materials;
(4) ‘Organic soil improver’ means a soil improver containing carbonaceous materials whose main function is to increase soil organic matter content;
(5) ‘Mulch’ means a type of soil improver used as protective covering placed around plants on the topsoil whose specific functions are to prevent the loss of moisture, control weed growth, and reduce soil erosion;
(6) ‘Organic mulch’ means mulch containing carbonaceous materials derived from biomass;
(7) ‘Constituent’ means any input material that can be used as an ingredient of the product;
(8) ‘Organic constituent’ means a constituent composed by carbonaceous materials;
(9) ‘Product family’ means the range of products composed by the same constituents;
(10) ‘Annual output’ means annual production of a product family;
(11) ‘Annual input’ means the annual amount of materials treated in a waste or animal by-product treatment plant;
(12) ‘Batch’ means quantity of goods manufactured by the same process under the same conditions and labelled in the same manner and is assumed to have the same characteristics;
(13) ‘Bio-waste’ means biodegradable garden and park waste, food and kitchen waste from households, restaurants, caterers and retail premises and comparable waste from food processing plants;
(14) ‘Biomass’ means the biodegradable fraction of products, waste and residues from biological origin from agriculture (including vegetal and animal substances), forestry and related industries including fisheries and aquaculture, as well as the biodegradable fraction of industrial and municipal waste.
Criterion 1 — Constituents
Criterion 2 — Organic constituents
Criterion 3 — Mineral growing media and mineral constituents
Criterion 3.1 — Energy consumption and CO2emissions
Criterion 3.2 — Sources of mineral extraction
Criterion 3.3 — Mineral growing media use and after use
Criterion 4 — Recycled/recovered and organic materials in growing media
Criterion 5 — Limitation of hazardous substances
Criterion 5.1 — Heavy metals
Criterion 5.2 — Polycyclic Aromatic Hydrocarbons
Criterion 5.3 — Hazardous substances and mixtures
Criterion 5.4 — Substances listed in accordance with Article 59(1) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council(1)
Criterion 5.5 — Limits forE. coliandSalmonellaspp.
Criterion 6 — Stability
Criterion 7 — Physical contaminants
Criterion 8 — Organic matter and dry matter
Criterion 9 — Viable weed seeds and plant propagules
Criterion 10 — Plant response
Criterion 11 — Growing media features
Criterion 12 — Provision of information
Criterion 13 — Information appearing on the EU Ecolabel
Criterion Growing media Soil improvers Mulch
Criterion 1 — Constituents x x x
Criterion 2 — Organic constituents x x x
Criterion 3.1. — Mineral growing media and mineral constituents: Energy consumption and CO2emissions x
Criterion 3.2 — Mineral growing media and mineral constituents: Sources of mineral extraction x x x
Criterion 3.3 — Mineral growing media and mineral constituents: Mineral growing media use and after use x
Criterion 4 — Recycled/recovered and organic materials in growing media x
Criterion 5 — Limitation of hazardous substances
Criterion 5.1 — Heavy metals x x x
Criterion 5.2 — Polycyclic Aromatic Hydrocarbons x x x
Criterion 5.3 — Hazardous substances and mixtures x x x
Criterion 5.4 — Substances listed in accordance with Article 59(1) of Regulation (EC) No 1907/2006 x x x
Criterion 5.5 — Limits forE. coliandSalmonellaspp. x x x
Criterion 6 — Stability x x x
Criterion 7 — Physical contaminants x x x
Criterion 8 — Organic matter and dry matter x x
Criterion 9 — Viable weed seeds and plant propagules x x
Criterion 10 — Plant response x x
Criterion 11 — Growing media features x
Criterion 12 — Provision of information x x x
Criterion 13 — Information appearing on the EU Ecolabel x x x
— Type 1 : Treatment plants for waste or for animal by-products
— Type 2 : Product manufacture plants using materials from Type 1 plants
— Type 3 : Product manufacture plants not using materials derived from waste or from animal by-products.
(1) The following materials are allowed as organic constituents of a final product.—Materials derived from the recycling of bio-waste from separate collection, as defined in Article 3 of Directive 2008/98/EC of the European Parliament and of the Council(3).—Materials derived from category 2 and 3 animal by-products as laid down in Article 32 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council(4)and technical standards which are laid down by implementing Regulation (EU) 142/2011.—Materials derived from faecal matter, straw and other natural non-hazardous agricultural or forestry material as defined in Article 2(1)(f) of Directive 2008/98/EC.—Materials derived from any other biomass by-products, as defined in Article 5 of Directive 2008/98/EC, that are not mentioned above, subject to the provisions of (2) and sub-criterion 2.3.—Materials derived from recycling or recovery of any other biomass waste not mentioned above, subject to the provisions of (2) and sub-criterion 2.3. — Materials derived from the recycling of bio-waste from separate collection, as defined in Article 3 of Directive 2008/98/EC of the European Parliament and of the Council(3). — Materials derived from category 2 and 3 animal by-products as laid down in Article 32 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council(4)and technical standards which are laid down by implementing Regulation (EU) 142/2011. — Materials derived from faecal matter, straw and other natural non-hazardous agricultural or forestry material as defined in Article 2(1)(f) of Directive 2008/98/EC. — Materials derived from any other biomass by-products, as defined in Article 5 of Directive 2008/98/EC, that are not mentioned above, subject to the provisions of (2) and sub-criterion 2.3. — Materials derived from recycling or recovery of any other biomass waste not mentioned above, subject to the provisions of (2) and sub-criterion 2.3.
— Materials derived from the recycling of bio-waste from separate collection, as defined in Article 3 of Directive 2008/98/EC of the European Parliament and of the Council(3).
— Materials derived from category 2 and 3 animal by-products as laid down in Article 32 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council(4)and technical standards which are laid down by implementing Regulation (EU) 142/2011.
— Materials derived from faecal matter, straw and other natural non-hazardous agricultural or forestry material as defined in Article 2(1)(f) of Directive 2008/98/EC.
— Materials derived from any other biomass by-products, as defined in Article 5 of Directive 2008/98/EC, that are not mentioned above, subject to the provisions of (2) and sub-criterion 2.3.
— Materials derived from recycling or recovery of any other biomass waste not mentioned above, subject to the provisions of (2) and sub-criterion 2.3.
— Materials derived from the recycling of bio-waste from separate collection, as defined in Article 3 of Directive 2008/98/EC of the European Parliament and of the Council(3).
— Materials derived from category 2 and 3 animal by-products as laid down in Article 32 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council(4)and technical standards which are laid down by implementing Regulation (EU) 142/2011.
— Materials derived from faecal matter, straw and other natural non-hazardous agricultural or forestry material as defined in Article 2(1)(f) of Directive 2008/98/EC.
— Materials derived from any other biomass by-products, as defined in Article 5 of Directive 2008/98/EC, that are not mentioned above, subject to the provisions of (2) and sub-criterion 2.3.
— Materials derived from recycling or recovery of any other biomass waste not mentioned above, subject to the provisions of (2) and sub-criterion 2.3.
(2) The following materials are not allowed as organic constituents of a final product.—Materials totally or partially derived from the organic fraction of mixed municipal household waste separated through mechanical, physicochemical, biological and/or manual treatment.—Materials totally or partially derived from sludges derived from municipal sewage water treatment and from sludges derived from the paper industry.—Materials totally or partially derived from sludges other than those allowed in Criterion 2.3.—Materials totally or partially derived from category 1 animal by-products according to Regulation (EC) No 1069/2009. — Materials totally or partially derived from the organic fraction of mixed municipal household waste separated through mechanical, physicochemical, biological and/or manual treatment. — Materials totally or partially derived from sludges derived from municipal sewage water treatment and from sludges derived from the paper industry. — Materials totally or partially derived from sludges other than those allowed in Criterion 2.3. — Materials totally or partially derived from category 1 animal by-products according to Regulation (EC) No 1069/2009.
— Materials totally or partially derived from the organic fraction of mixed municipal household waste separated through mechanical, physicochemical, biological and/or manual treatment.
— Materials totally or partially derived from sludges derived from municipal sewage water treatment and from sludges derived from the paper industry.
— Materials totally or partially derived from sludges other than those allowed in Criterion 2.3.
— Materials totally or partially derived from category 1 animal by-products according to Regulation (EC) No 1069/2009.
— Materials totally or partially derived from the organic fraction of mixed municipal household waste separated through mechanical, physicochemical, biological and/or manual treatment.
— Materials totally or partially derived from sludges derived from municipal sewage water treatment and from sludges derived from the paper industry.
— Materials totally or partially derived from sludges other than those allowed in Criterion 2.3.
— Materials totally or partially derived from category 1 animal by-products according to Regulation (EC) No 1069/2009.
(a) they are identified as one of the following types of waste according to the European List of Wastes, as defined by Commission Decision 2000/532/EC(5)presented in Table 2:Table 2Sludges allowed and their codes according to the European List of Wastes0203 05sludges from on-site effluent treatment in the preparation and processing of fruit, vegetables, cereals, edible oils, cocoa, coffee, tea and tobacco, conserve production, yeast and yeast extract production, molasses preparation and fermentation;0204 03sludges from on-site effluent treatment in sugar processing;0205 02sludges from on-site effluent treatment in the dairy products industry;0206 03sludges from on-site effluent treatment in the baking and confectionery industry;0207 05sludges from on-site effluent treatment in the production of alcoholic and non-alcoholic beverages (except coffee, tea and cocoa). 0203 05 sludges from on-site effluent treatment in the preparation and processing of fruit, vegetables, cereals, edible oils, cocoa, coffee, tea and tobacco, conserve production, yeast and yeast extract production, molasses preparation and fermentation; 0204 03 sludges from on-site effluent treatment in sugar processing; 0205 02 sludges from on-site effluent treatment in the dairy products industry; 0206 03 sludges from on-site effluent treatment in the baking and confectionery industry; 0207 05 sludges from on-site effluent treatment in the production of alcoholic and non-alcoholic beverages (except coffee, tea and cocoa).
0203 05 sludges from on-site effluent treatment in the preparation and processing of fruit, vegetables, cereals, edible oils, cocoa, coffee, tea and tobacco, conserve production, yeast and yeast extract production, molasses preparation and fermentation;
0204 03 sludges from on-site effluent treatment in sugar processing;
0205 02 sludges from on-site effluent treatment in the dairy products industry;
0206 03 sludges from on-site effluent treatment in the baking and confectionery industry;
0207 05 sludges from on-site effluent treatment in the production of alcoholic and non-alcoholic beverages (except coffee, tea and cocoa).
0203 05 sludges from on-site effluent treatment in the preparation and processing of fruit, vegetables, cereals, edible oils, cocoa, coffee, tea and tobacco, conserve production, yeast and yeast extract production, molasses preparation and fermentation;
0204 03 sludges from on-site effluent treatment in sugar processing;
0205 02 sludges from on-site effluent treatment in the dairy products industry;
0206 03 sludges from on-site effluent treatment in the baking and confectionery industry;
0207 05 sludges from on-site effluent treatment in the production of alcoholic and non-alcoholic beverages (except coffee, tea and cocoa).
(b) they are single-source separated, meaning that there has been no mixing with effluents or sludges outside a specific production process.
— Energy consumption/product ≤ 11 GJ/t product
— CO2emissions/product ≤ 0,8 t CO2/t product
— nis the number of years of the period used to calculate the average
— iis each year of the period used to calculate the average
— Productionis the production of mineral wool or expanded minerals in tonnes in the yeari
— Fis the annual consumption of fuels in the production process in the yeari
— Elgridis the annual electricity consumption from the grid in the yeari
— Hcogis the annual consumption of useful heat from cogeneration in the yeari
— Elcogis the annual consumption of electricity from cogeneration in the yeari
— Ref HηandRef Eηare the reference efficiencies for the separate production of heat and electricity as defined in the Directive 2012/27/EU of the European Parliament and of the Council(6)and calculated according to the Commission Implementing Decision 2011/877/EU(7)
— PEScogis the primary energy saving of the cogeneration plant as defined in the Directive 2012/27/EU, in the yeari
— nis the number of years of the period used to calculate the average
— iis each year of the period used to calculate the average
— Productionis the mineral wool production in tonnes in the yeari
— Direct CO2is the CO2emissions as defined in Commission Regulation (EU) No 601/2012(8), in the yeari
— Indirect CO2is the indirect CO2emissions due to final energy consumption in the yeari, and shall be calculated as:
— FEgridis the EU average carbon intensity of the electricity grid, according to MEErP(9)methodology (0,384 tCO2/MWhe = 0,107 tCO2/GJe)
— FEfuel cogis the CO2emission factor of the fuel consumed in the cogeneration plant
— Ratio energy consumption (GJ)/product (tonne).
— Ratio CO2emissions (tonne)/product (tonne).
— Direct CO2emissions (tonnes) for each year of the period to calculate the average.
— Indirect CO2emissions (tonnes) for each year of the period to calculate the average.
— Fuels consumed, consumption of each fuel (GJ), sub-process/es of the manufacture process where they are consumed for each year of the period to calculate the average.
— Electricity consumption from the grid (GJ final energy) for each year of the period to calculate the average.
— Useful heat consumption from cogeneration (GJ final energy) for each year of the period to calculate the average.
— Electricity consumption from cogeneration (GJ final energy) for each year of the period to calculate the average.
— Reference efficiencies for separate production of heat and electricity.
— Primary energy saving (PES) (%) of the cogeneration for each year of the period to calculate the average.
— Identification of fuels used in cogeneration and their share in the fuel mix, for each year of the period to calculate the average.
— Annual emissions report according to Regulation (EU) No 601/2012, for each year of the period to calculate the average.
— Verification report finding the annual emissions report satisfactory according to Commission Regulation (EU) No 600/2012(10), for each year of the period to calculate the average.
— Records of electricity consumption from the grid provided by the supplier, for each year of the period to calculate the average.
— Records of the useful heat and electricity consumption from cogeneration, both on-site and purchased, for each year of the period to calculate the average.
(1) (Within the EU): If they are extracted from Natura 2000 network areas, composed of Special Protection Areas under Directive 2009/147/EC of the European Parliament and of the Council(11)on the conservation of wild birds, and Special Areas of Conservation under Council Directive 92/43/EEC(12)on the conservation of natural habitats and wild fauna and flora, extraction activities have been assessed and authorised in accordance with the provisions of Article 6 of Directive 92/43/EEC and taking into account the EC Guidance document on non-energy mineral extraction and Natura 2000(13);
(2) (Outside the EU): If they are extracted from protected areas designated as such under the national legislation of the sourcing/exporting countries, the extraction activities have been assessed and authorised in accordance with provisions that provide assurances equivalent to those under (1).
— Contract documentation between the manufacturer and the service providers.
— Description of collection, processing and destinations.
— Annual overview of the total sales volume of growing media in the European Union Member States and an annual overview of the sales volumes in areas of those Member States where collection and processing are on offer.
— In case of new entrants, an estimation of the annual overview of the total sales volume of growing media in the European Union Member States and an estimation of the annual overview of the sales volumes in areas of those Member States where collection and processing are on offer, shall be provided. Real data shall be provided 1 year after the EU Ecolabel license is awarded.
(a) The growing medium shall contain a minimum of 30 % of organic constituents (expressed as volume of organic constituent per total volume of the final product); or
(b) The mineral growing medium shall contain mineral constituents manufactured from a process using at least 30 % of recycled materials (expressed as the dry weight of recycled/recovered materials per total dry weight of the input materials).
— for the case (a): volume of organic constituents declared in Criterion 1 per total volume of the final product, or
— for the case (b): dry weight of recycled/recovered materials per total dry weight of the input materials.
— identification of raw material inputs, dry weight of the raw material input per total dry weight of the input materials, and origin, for each raw material input, and
— identification of recycled/recovered material inputs, dry weight of recycled/recovered material input per total dry weight of the input materials and origin, for each recycled/recovered material input.
Heavy metal Maximum content in the product (mg/kg DW)
Cadmium (Cd) 1
Chromium total (Cr) 100
Copper (Cu) 100
Mercury (Hg) 1
Nickel (Ni) 50
Lead (Pb) 100
Zinc (Zn) 300
Heavy metal Maximum content in the product (mg/kg DW)
Cadmium (Cd) 3
Chromium total (Cr) 150
Copper (Cu) 100
Mercury (Hg) 1
Nickel (Ni) 90
Lead (Pb) 150
Zinc (Zn) 300
Heavy metals Method of measurement Method of extraction
Cadmium (Cd) EN 13650 For soil improvers, mulch, organic constituents of growing media and growing media, except mineral growing media:EN 13650 Soil improvers and growing media — Extraction of aqua regia soluble elementsFor mineral growing media:EN 13651 Soil improvers and growing media — Extraction of calcium chloride/DTPA (CAT) soluble nutrients and elements
Chromium total (Cr) EN 13650
Copper (Cu) EN 13650
Mercury (Hg) EN 16175(14)
Nickel (Ni) EN 13650
Lead (Pb) EN 13650
Zinc (Zn) EN 13650
Pollutant Maximum content in the product (mg/kg DW)
PAH16 6
PAH16= sum of naphthalene, acenaphtylene, acenaphtene, fluorene, phenanthrene, anthracene, fluoranthene, pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, indeno[1,2,3-cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene
Acute toxicity
Category 1 and 2 Category 3
H300 Fatal if swallowed H301 Toxic if swallowed
H310 Fatal in contact with skin H311 Toxic in contact with skin
H330 Fatal if inhaled H331 Toxic if inhaled
H304 May be fatal if swallowed and enters airways EUH070 Toxic by eye contact
Specific target organ toxicity
Category 1 Category 2
H370 Causes damage to organs H371 May cause damage to organs
H372 Causes damage to organs through prolonged or repeated exposure H373 May cause damage to organs through prolonged or repeated exposure
Respiratory and skin sensitisation
Category 1A Category 1B
H317: May cause allergic skin reaction H317: May cause allergic skin reaction
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled
Carcinogenic, mutagenic or toxic for reproduction
Category 1A and 1B Category 2
H340 May cause genetic defects H341 Suspected of causing genetic defects
H350 May cause cancer H351 Suspected of causing cancer
H350i May cause cancer by inhalation
H360F May damage fertility H361f Suspected of damaging fertility
H360D May damage the unborn child H361d Suspected of damaging the unborn child
H360FD May damage fertility. May damage the unborn child H361fd Suspected of damaging fertility. Suspected of damaging the unborn child
H360Fd May damage fertility. Suspected of damaging the unborn child H362 May cause harm to breast fed children
H360Df May damage the unborn child. Suspected of damaging fertility
Hazardous to the aquatic environment
Category 1 and 2 Category 3 and 4
H400 Very toxic to aquatic life H412 Harmful to aquatic life with long-lasting effects
H410 Very toxic to aquatic life with long-lasting effects H413 May cause long-lasting effects to aquatic life
H411 Toxic to aquatic life with long-lasting effects
Hazardous to the ozone layer
H420 Hazardous to the ozone layer
— Materials not included in the scope of the Regulation (EC) No 1907/2006 according its Article 2(2).
— Substances covered by Article 2(7)(b) of the Regulation (EC) No 1907/2006,which sets out criteria for exempting substances within Annex V to that Regulation from the registration, downstream user and evaluation requirements.
(i) for substances that have not been registered under Regulation (EC) No 1907/2006 or which do not yet have a harmonised CLP classification: information meeting the requirements listed in Annex VII to that Regulation;
(ii) for substances that have been registered under Regulation (EC) No 1907/2006 and which do not meet the requirements for CLP classification: information based on the REACH registration dossier confirming the non-classified status of the substance;
(iii) for substances that have a harmonised classification or are self-classified: safety data sheets where available. If these are not available or the substance is self-classified then information shall be provided relevant to the substances hazard classification in accordance with Annex II to Regulation (EC) No 1907/2006;
(iv) in the case of mixtures: safety data sheets where available. If these are not available then calculation of the mixture classification shall be provided according to the rules under Regulation (EC) No 1272/2008 together with information relevant to the mixtures hazard classification in accordance with Annex II to Regulation (EC) No 1907/2006.
(a) Certificate awarded for the right to use the European Certification Board for Mineral Wool Products trademark to demonstrate compliance with the Note Q within the Regulation (EC) No 1272/2008.
(b) Test report according to ISO 14184-1 Textiles — Determination of formaldehyde — Part 1: Free and hydrolysed formaldehyde.
Pathogen Limit
E. coli 1 000 CFU/g fresh weight
Salmonellaspp. absent in 25 g fresh weight
CFU= colony-forming units.
Parameter Test method
E. coli CEN/TR 16193 Sludge, treated biowaste and soil. Detection and enumeration ofEscherichia colior equivalent
Salmonellaspp. ISO 6579 Microbiology of food and animal feeding stuffs — Horizontal method for the detection ofSalmonellaspp.
Stability parameter Requirement
Maximum Respirometric index 15 mmol O2/kg organic matter/h
Minimum Rottegrad, where applicable IV (self-heating test temperature rise of maximum 20 °C above ambient temperature)
Stability parameter Requirement
Maximum Respirometric index 25 mmol O2/kg organic matter/h
Minimum Rottegrad, where applicable III (self-heating test temperature rise of maximum 30 °C above ambient temperature)
Parameter Test method
Respirometric index EN 16087-1 Soil improvers and growing media — Determination of the aerobic biological activity. Oxygen uptake rate (OUR)
Rottegrad EN 16087-2 Soil improvers and growing media. Determination of the aerobic biological activity. Self-heating test for compost
Parameter Test method
Dry matter (% FW) EN 13040 Soil improvers and growing media. Sample preparation for chemical and physical tests, determination of dry matter content, moisture content and laboratory compacted bulk density
Organic matter as Loss on Ignition (% DM) EN 13039 Soil improvers and growing media. Determination of organic matter content and ash
(a) The name and address of the body responsible for marketing;
(b) A descriptor identifying the product by type, including the wording ‘SOIL IMPROVER’;
(c) A batch identification code;
(d) The quantity (in weight);
(e) Range of moisture content;
(f) The main materials (those over 5 % by weight) from which the product has been manufactured;
(g) The recommended conditions of storage and the recommended ‘use by’ date;
(h) Guidelines for safe handling and use;
(i) A description of the purpose for which the product is intended and any limitations on use, including a statement about the suitability of the product for particular plant groups (e.g. calcifuges or calcicoles);
(j) pH (reference of the test method used);
(k) Organic carbon content (%), total nitrogen content (%) and inorganic nitrogen content (%) (reference to the test method used);
(l) Carbon/Nitrogen ratio;
(m) Total phosphorus (%) and total potassium (%) (reference to the test method used);
(n) For products for non-professional use, a statement about the stability of organic matter (stable or very stable);
(o) A statement on recommended methods of use;
(p) In non-professional applications: recommended rate of application expressed in kilograms of product per unit surface area (m2) per annum.
(a) The name and address of the body responsible for marketing;
(b) A descriptor identifying the product by type, including the wording ‘GROWING MEDIUM’;
(c) A batch identification code;
(d) The quantity (in volume or number of slabs, in case of mineral wool, specifying the dimensions of the slab);
(e) Range of moisture content;
(f) The main materials (those over 5 % by volume) from which the product has been manufactured;
(g) The recommended conditions of storage and the recommended ‘use by’ date;
(h) Guidelines for safe handling and use;
(i) A description of the purpose for which the product is intended and any limitations on use, including a statement about the suitability of the product for particular plant groups (e.g. calcifuges or calcicoles);
(j) pH (EN 13037);
(k) Electrical Conductivity (1:5 extraction);
(l) Germination inhibition (EN 16086-1);
(m) Growth inhibition (EN 16086-1);
(n) A statement about the stability of organic matter (stable or very stable);
(o) A statement on recommended methods of use;
(p) For mineral growing media, a statement about the professional horticultural application.
(a) The name and address of the body responsible for marketing;
(b) A descriptor identifying the product by type, including the wording ‘MULCH’;
(c) A batch identification code;
(d) The quantity (in volume);
(e) Range of moisture content;
(f) The main materials (those over 5 % by volume) from which the product has been manufactured;
(g) Guidelines for safe handling and use;
(h) A description of the purpose for which the product is intended and any limitations on use, including a statement about the suitability of the product for particular plant groups (e.g. calcifuges or calcicoles);
(i) pH (reference of the test method used);
(j) A statement about the stability of organic matter (stable or very stable), where applicable, for non-professional uses;
(k) A statement on recommended methods of use;
(l) In non-professional applications: recommended rate of application expressed in mm.
— promotes the recycling of materials
— promotes the use of renewable and recycled materials
— reduces soil and water pollution, by limiting heavy metals concentrations
Type of plant Criterion Annual input/output Test frequency
Type 1: Treatment plants for waste or for animal by-products 5.1—Limits for heavy metals5.5—Limits forE. coliandSalmonellaspp.6—Stability7—Physical contaminants8—Organic matter and dry matter9—Viable seeds and plant propagules10—Plant response11—Growing media features 5.1 — Limits for heavy metals 5.5 — Limits forE. coliandSalmonellaspp. 6 — Stability 7 — Physical contaminants 8 — Organic matter and dry matter 9 — Viable seeds and plant propagules 10 — Plant response 11 — Growing media features Input (t) ≤ 3 000 1 every 1 000 tonnes input material rounded to the next integer
5.1 — Limits for heavy metals
5.5 — Limits forE. coliandSalmonellaspp.
6 — Stability
7 — Physical contaminants
8 — Organic matter and dry matter
9 — Viable seeds and plant propagules
10 — Plant response
11 — Growing media features
3 000 < input (t) ≤ 20 000 4 (one sample every season)
Input (t) > 20 000 number of analyses per year = amount of annual input material (in tonnes)/10 000 tonne + 1Minimum 4 and maximum 12
5.2—PAH 5.2 — PAH Input (t) ≤ 3 000 1
5.2 — PAH
3 000 < input (t) ≤ 10 000 2
10 000 < input (t) ≤ 20 000 3
20 000 < input (t) ≤ 40 000 4
40 000 < input (t) ≤ 60 000 5
60 000 < input (t) ≤ 80 000 6
80 000 < input (t) ≤ 100 000 7
100 000 < input (t) ≤ 120 000 8
120 000 < input (t) ≤ 140 000 9
140 000 < input (t) ≤ 160 000 10
160 000 < input (t) ≤ 180 000 11
Input (t) > 180 000 12
Type 2: Product manufacture plants using materials from Type 1 plants 5.1—Limits for heavy metals5.5—Limits forE. coliandSalmonellaspp.6—Stability7—Physical contaminants8—Organic matter and dry matter9—Viable seeds and plant propagules10—Plant response11—Growing media features 5.1 — Limits for heavy metals 5.5 — Limits forE. coliandSalmonellaspp. 6 — Stability 7 — Physical contaminants 8 — Organic matter and dry matter 9 — Viable seeds and plant propagules 10 — Plant response 11 — Growing media features Output (m3) ≤ 5 000 Representative combined samples from 2 batches according EN 12579(1)
5.1 — Limits for heavy metals
5.5 — Limits forE. coliandSalmonellaspp.
6 — Stability
7 — Physical contaminants
8 — Organic matter and dry matter
9 — Viable seeds and plant propagules
10 — Plant response
11 — Growing media features
Output (m3) > 5 000 Representative combined samples from 4 batches according EN 12579
5.2—PAH 5.2 — PAH Output (m3) ≤ 5 000 Representative combined sample(s) from 1 batch according EN 12579
5.2 — PAH
Output (m3) > 5 000 Representative combined samples from 2 batches according EN 12579
Type 3: Product manufacture plants NOT using materials derived from waste or from animal by-products 5.1—Limits for heavy metals5.5—Limits forE. coliandSalmonellaspp.6—Stability7—Physical contaminants8—Organic matter and dry matter9—Viable seeds and plant propagules10—Plant response11—Growing media features 5.1 — Limits for heavy metals 5.5 — Limits forE. coliandSalmonellaspp. 6 — Stability 7 — Physical contaminants 8 — Organic matter and dry matter 9 — Viable seeds and plant propagules 10 — Plant response 11 — Growing media features Output (m3) ≤ 5 000 Representative combined sample(s) from 1 batch according EN 12579
5.1 — Limits for heavy metals
5.5 — Limits forE. coliandSalmonellaspp.
6 — Stability
7 — Physical contaminants
8 — Organic matter and dry matter
9 — Viable seeds and plant propagules
10 — Plant response
11 — Growing media features
Output (m3) > 5 000 Representative combined samples from 2 batches according EN 12579
5.2—PAH 5.2 — PAH Regardless the input/output Representative combined sample(s) from 1 batch according EN 12579
5.2 — PAH
5.1 — Limits for heavy metals
5.5 — Limits forE. coliandSalmonellaspp.
6 — Stability
7 — Physical contaminants
8 — Organic matter and dry matter
9 — Viable seeds and plant propagules
10 — Plant response
11 — Growing media features
5.2 — PAH
5.1 — Limits for heavy metals
5.5 — Limits forE. coliandSalmonellaspp.
6 — Stability
7 — Physical contaminants
8 — Organic matter and dry matter
9 — Viable seeds and plant propagules
10 — Plant response
11 — Growing media features
5.2 — PAH
5.1 — Limits for heavy metals
5.5 — Limits forE. coliandSalmonellaspp.
6 — Stability
7 — Physical contaminants
8 — Organic matter and dry matter
9 — Viable seeds and plant propagules
10 — Plant response
11 — Growing media features
5.2 — PAH
Type of plant Criteria Annual input/output Test frequency
Type 1: Treatment plants for waste or for animal by-products 5.1—Limits for heavy metals5.5—Limits forE. coliandSalmonellaspp.6—Stability7—Physical contaminants8—Organic matter and dry matter9—Viable seeds and plant propagules10—Plant response11—Growing media features 5.1 — Limits for heavy metals 5.5 — Limits forE. coliandSalmonellaspp. 6 — Stability 7 — Physical contaminants 8 — Organic matter and dry matter 9 — Viable seeds and plant propagules 10 — Plant response 11 — Growing media features Input (t) ≤ 1 000 1
5.1 — Limits for heavy metals
5.5 — Limits forE. coliandSalmonellaspp.
6 — Stability
7 — Physical contaminants
8 — Organic matter and dry matter
9 — Viable seeds and plant propagules
10 — Plant response
11 — Growing media features
Input (t) > 1 000 number of analyses per year = amount of annual input material (in tonnes)/10 000 tonnes + 1Minimum 2 and maximum 12
5.2—PAH 5.2 — PAH Input (t) ≤ 10 000 0,25 (once per 4 years)
5.2 — PAH
10 000 < input (t) ≤ 25 000 0,5 (once per 2 years)
25 000 < input (t) ≤ 50 000 1
50 000 < input (t) ≤ 100 000 2
100 000 < input (t) ≤ 150 000 3
150 000 < input (t) ≤ 200 000 4
200 000 < input (t) ≤ 250 000 5
250 000 < input (t) ≤ 300 000 6
300 000 < input (t) ≤ 350 000 7
350 000 < input (t) ≤ 400 000 8
400 000 < input (t) ≤ 450 000 9
450 000 < input (t) ≤ 500 000 10
500 000 < input (t) ≤ 550 000 11
Input (t) > 550 000 12
Type 2: Product manufacture plants using materials from Type 1 plants 5.1—Limits for heavy metals5.5—Limits forE. coliandSalmonellaspp.6—Stability7—Physical contaminants8—Organic matter and dry matter9—Viable seeds and plant propagules10—Plant response11—Growing media features 5.1 — Limits for heavy metals 5.5 — Limits forE. coliandSalmonellaspp. 6 — Stability 7 — Physical contaminants 8 — Organic matter and dry matter 9 — Viable seeds and plant propagules 10 — Plant response 11 — Growing media features Output (m3) ≤ 5 000 Representative combined sample(s) from 1 batch according EN 12579
5.1 — Limits for heavy metals
5.5 — Limits forE. coliandSalmonellaspp.
6 — Stability
7 — Physical contaminants
8 — Organic matter and dry matter
9 — Viable seeds and plant propagules
10 — Plant response
11 — Growing media features
Output (m3) > 5 000 Representative combined samples from 2 batches according EN 12579
5.2—PAH 5.2 — PAH Output (m3) ≤ 15 000 Representative combined sample(s) from 1 batch according EN 12579, once each 4 years
5.2 — PAH
15 000 < Output (m3) ≤ 40 000 Representative combined sample(s) from 1 batch according EN 12579, each 2 years
Output (m3) > 40 000 Representative combined sample(s) from 1 batch according EN 12579, each year
Type 3: Product manufacture plants NOT using materials derived from waste or from animal by-products 5.1—Limits for heavy metals5.5—Limits forE. coliandSalmonellaspp.6—Stability7—Physical contaminants8—Organic matter and dry matter9—Viable weed seeds and plant propagules10—Plant response11—Growing media features 5.1 — Limits for heavy metals 5.5 — Limits forE. coliandSalmonellaspp. 6 — Stability 7 — Physical contaminants 8 — Organic matter and dry matter 9 — Viable weed seeds and plant propagules 10 — Plant response 11 — Growing media features Regardless the input/output Representative combined sample(s) from 1 batch according EN 12579
5.1 — Limits for heavy metals
5.5 — Limits forE. coliandSalmonellaspp.
6 — Stability
7 — Physical contaminants
8 — Organic matter and dry matter
9 — Viable weed seeds and plant propagules
10 — Plant response
11 — Growing media features
5.2—PAH 5.2 — PAH Regardless the input/output Representative combined sample(s) from 1 batch according EN 12579, once each 4 years
5.2 — PAH
5.1 — Limits for heavy metals
5.5 — Limits forE. coliandSalmonellaspp.
6 — Stability
7 — Physical contaminants
8 — Organic matter and dry matter
9 — Viable seeds and plant propagules
10 — Plant response
11 — Growing media features
5.2 — PAH
5.1 — Limits for heavy metals
5.5 — Limits forE. coliandSalmonellaspp.
6 — Stability
7 — Physical contaminants
8 — Organic matter and dry matter
9 — Viable seeds and plant propagules
10 — Plant response
11 — Growing media features
5.2 — PAH
5.1 — Limits for heavy metals
5.5 — Limits forE. coliandSalmonellaspp.
6 — Stability
7 — Physical contaminants
8 — Organic matter and dry matter
9 — Viable weed seeds and plant propagules
10 — Plant response
11 — Growing media features
5.2 — PAH
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel(1), and in particular Article 8(2) thereof,
After consulting the European Union Eco-labelling Board,
(1) Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to products which have a reduced environmental impact during their entire life cycle.
(2) Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.
(3) Commission Decision 2006/799/EC(2)and Commission Decision 2007/64/EC(3)have established the ecological criteria and the related assessment and verification requirements for soil improvers and growing media, respectively, which are valid until 31 December 2015.
(4) In order to better reflect the state of the art of the market for these product groups and take into account the innovation of the last years, it is considered appropriate to merge both product groups into one product group and add mulch to its scope, as it is distinguished as a type of soil improver with particular characteristics and functions.
(5) The revised criteria, as well as the related assessment and verification requirements should be valid for 4 years from the date of adoption of this Decision, taking into account the innovation cycle for this product group. These criteria aim at promoting the recycling of materials, the use of renewable and recycled materials, thus reducing environmental degradation, and decreasing soil and water pollution by means of establishing strict limits on pollutants concentrations in the final product.
(6) Decision 2006/799/EC and Decision 2007/64/EC should therefore be replaced by this Decision.
(7) A transitional period should be allowed for producers whose products have been awarded the EU Ecolabel for soil improvers and growing media on the basis of the criteria set out in Decision 2006/799/EC and Decision 2007/64/EC, respectively, so that they have sufficient time to adapt their products to comply with the revised criteria and requirements.
(8) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,
HAS ADOPTED THIS DECISION:

Article 1
The product group ‘growing media, soil improvers and mulch’ shall comprise growing media, organic soil improvers and organic mulch.

Article 2
For the purpose of this Decision, the following definitions shall apply:
(1)
‘Growing medium’ means a material used as a substrate for root development, in which plants are grown;
(2)
‘Mineral growing medium’ means a growing medium totally composed by mineral constituents;
(3)
‘Soil improver’ means a material added to soil in situ whose main function is to maintain or improve its physical and/or chemical and/or biological properties, with the exception of liming materials;
(4)
‘Organic soil improver’ means a soil improver containing carbonaceous materials whose main function is to increase soil organic matter content;
(5)
‘Mulch’ means a type of soil improver used as protective covering placed around plants on the topsoil whose specific functions are to prevent the loss of moisture, control weed growth, and reduce soil erosion;
(6)
‘Organic mulch’ means mulch containing carbonaceous materials derived from biomass;
(7)
‘Constituent’ means any input material that can be used as an ingredient of the product;
(8)
‘Organic constituent’ means a constituent composed by carbonaceous materials;
(9)
‘Product family’ means the range of products composed by the same constituents;
(10)
‘Annual output’ means annual production of a product family;
(11)
‘Annual input’ means the annual amount of materials treated in a waste or animal by-product treatment plant;
(12)
‘Batch’ means quantity of goods manufactured by the same process under the same conditions and labelled in the same manner and is assumed to have the same characteristics;
(13)
‘Bio-waste’ means biodegradable garden and park waste, food and kitchen waste from households, restaurants, caterers and retail premises and comparable waste from food processing plants;
(14)
‘Biomass’ means the biodegradable fraction of products, waste and residues from biological origin from agriculture (including vegetal and animal substances), forestry and related industries including fisheries and aquaculture, as well as the biodegradable fraction of industrial and municipal waste.

Article 3
In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, a product shall fall within the product group ‘growing media, soil improvers and mulch’, as defined in Article 1 of this Decision and shall comply with the criteria as well as the related assessment and verification requirements set out in the Annex.

Article 4
The criteria for the product group ‘growing media, soil improvers and mulch’ and the related assessment and verification requirements shall be valid for 4 years from the date of adoption of this Decision.

Article 5
For administrative purposes the code number assigned to the product group ‘growing media, soil improvers and mulch’ shall be ‘048’.

Article 6
Decision 2006/799/EC and Decision 2007/64/EC are repealed.

Article 7
1. By derogation from Article 6, applications for the EU Ecolabel for products falling within the product groups ‘soil improvers’ or ‘growing media’ submitted before the date of adoption of this Decision shall be evaluated in accordance with the conditions laid down in Decision 2006/799/EC and Decision 2007/64/EC, respectively.
2. Applications for the EU Ecolabel for products falling within the product groups ‘soil improvers’ or ‘growing media’ submitted within 2 months from the date of adoption of this Decision may be based either on the criteria set out in Decision 2006/799/EC and Decision 2007/64/EC, respectively, or on the criteria set out in this Decision. Those applications shall be evaluated in accordance with the criteria on which they are based.
3. EU Ecolabel licences awarded in accordance with the criteria set out in Decision 2006/799/EC and Decision 2007/64/EC may be used for 12 months from the date of adoption of this Decision.

Article 8
This Decision is addressed to the Member States.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel(1), and in particular Article 8(2) thereof,
After consulting the European Union Eco-labelling Board,
(1) Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to products which have a reduced environmental impact during their entire life cycle.
(2) Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.
(3) Commission Decision 2006/799/EC(2)and Commission Decision 2007/64/EC(3)have established the ecological criteria and the related assessment and verification requirements for soil improvers and growing media, respectively, which are valid until 31 December 2015.
(4) In order to better reflect the state of the art of the market for these product groups and take into account the innovation of the last years, it is considered appropriate to merge both product groups into one product group and add mulch to its scope, as it is distinguished as a type of soil improver with particular characteristics and functions.
(5) The revised criteria, as well as the related assessment and verification requirements should be valid for 4 years from the date of adoption of this Decision, taking into account the innovation cycle for this product group. These criteria aim at promoting the recycling of materials, the use of renewable and recycled materials, thus reducing environmental degradation, and decreasing soil and water pollution by means of establishing strict limits on pollutants concentrations in the final product.
(6) Decision 2006/799/EC and Decision 2007/64/EC should therefore be replaced by this Decision.
(7) A transitional period should be allowed for producers whose products have been awarded the EU Ecolabel for soil improvers and growing media on the basis of the criteria set out in Decision 2006/799/EC and Decision 2007/64/EC, respectively, so that they have sufficient time to adapt their products to comply with the revised criteria and requirements.
(8) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,
HAS ADOPTED THIS DECISION:
The product group ‘growing media, soil improvers and mulch’ shall comprise growing media, organic soil improvers and organic mulch.
For the purpose of this Decision, the following definitions shall apply:
(1)
‘Growing medium’ means a material used as a substrate for root development, in which plants are grown;
(2)
‘Mineral growing medium’ means a growing medium totally composed by mineral constituents;
(3)
‘Soil improver’ means a material added to soil in situ whose main function is to maintain or improve its physical and/or chemical and/or biological properties, with the exception of liming materials;
(4)
‘Organic soil improver’ means a soil improver containing carbonaceous materials whose main function is to increase soil organic matter content;
(5)
‘Mulch’ means a type of soil improver used as protective covering placed around plants on the topsoil whose specific functions are to prevent the loss of moisture, control weed growth, and reduce soil erosion;
(6)
‘Organic mulch’ means mulch containing carbonaceous materials derived from biomass;
(7)
‘Constituent’ means any input material that can be used as an ingredient of the product;
(8)
‘Organic constituent’ means a constituent composed by carbonaceous materials;
(9)
‘Product family’ means the range of products composed by the same constituents;
(10)
‘Annual output’ means annual production of a product family;
(11)
‘Annual input’ means the annual amount of materials treated in a waste or animal by-product treatment plant;
(12)
‘Batch’ means quantity of goods manufactured by the same process under the same conditions and labelled in the same manner and is assumed to have the same characteristics;
(13)
‘Bio-waste’ means biodegradable garden and park waste, food and kitchen waste from households, restaurants, caterers and retail premises and comparable waste from food processing plants;
(14)
‘Biomass’ means the biodegradable fraction of products, waste and residues from biological origin from agriculture (including vegetal and animal substances), forestry and related industries including fisheries and aquaculture, as well as the biodegradable fraction of industrial and municipal waste.
In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, a product shall fall within the product group ‘growing media, soil improvers and mulch’, as defined in Article 1 of this Decision and shall comply with the criteria as well as the related assessment and verification requirements set out in the Annex.
The criteria for the product group ‘growing media, soil improvers and mulch’ and the related assessment and verification requirements shall be valid for 4 years from the date of adoption of this Decision.
For administrative purposes the code number assigned to the product group ‘growing media, soil improvers and mulch’ shall be ‘048’.
Decision 2006/799/EC and Decision 2007/64/EC are repealed.
1. By derogation from Article 6, applications for the EU Ecolabel for products falling within the product groups ‘soil improvers’ or ‘growing media’ submitted before the date of adoption of this Decision shall be evaluated in accordance with the conditions laid down in Decision 2006/799/EC and Decision 2007/64/EC, respectively.
2. Applications for the EU Ecolabel for products falling within the product groups ‘soil improvers’ or ‘growing media’ submitted within 2 months from the date of adoption of this Decision may be based either on the criteria set out in Decision 2006/799/EC and Decision 2007/64/EC, respectively, or on the criteria set out in this Decision. Those applications shall be evaluated in accordance with the criteria on which they are based.
3. EU Ecolabel licences awarded in accordance with the criteria set out in Decision 2006/799/EC and Decision 2007/64/EC may be used for 12 months from the date of adoption of this Decision.
This Decision is addressed to the Member States.

FRAMEWORK

ANNEXEU ECOLABEL CRITERIACriteria for awarding the EU Ecolabel to growing media, soil improvers and mulch:

Criterion 1 | — Constituents |
Criterion 2 | — Organic constituents |
Criterion 3 | — Mineral growing media and mineral constituents |
Criterion 3.1 | — Energy consumption and CO2emissions |
Criterion 3.2 | — Sources of mineral extraction |
Criterion 3.3 | — Mineral growing media use and after use |
Criterion 4 | — Recycled/recovered and organic materials in growing media |
Criterion 5 | — Limitation of hazardous substances |
Criterion 5.1 | — Heavy metals |
Criterion 5.2 | — Polycyclic Aromatic Hydrocarbons |
Criterion 5.3 | — Hazardous substances and mixtures |
Criterion 5.4 | — Substances listed in accordance with Article 59(1) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council(1) |
Criterion 5.5 | — Limits forE. coliandSalmonellaspp. |
Criterion 6 | — Stability |
Criterion 7 | — Physical contaminants |
Criterion 8 | — Organic matter and dry matter |
Criterion 9 | — Viable weed seeds and plant propagules |
Criterion 10 | — Plant response |
Criterion 11 | — Growing media features |
Criterion 12 | — Provision of information |
Criterion 13 | — Information appearing on the EU Ecolabel |
Table 1

Applicability of the different criteria to each type of product covered by the scope

Criterion | Growing media | Soil improvers | Mulch
Criterion 1 — Constituents | x | x | x
Criterion 2 — Organic constituents | x | x | x
Criterion 3.1. — Mineral growing media and mineral constituents: Energy consumption and CO2emissions | x | |
Criterion 3.2 — Mineral growing media and mineral constituents: Sources of mineral extraction | x | x | x
Criterion 3.3 — Mineral growing media and mineral constituents: Mineral growing media use and after use | x | |
Criterion 4 — Recycled/recovered and organic materials in growing media | x | |
Criterion 5 — Limitation of hazardous substances | | |
Criterion 5.1 — Heavy metals | x | x | x
Criterion 5.2 — Polycyclic Aromatic Hydrocarbons | x | x | x
Criterion 5.3 — Hazardous substances and mixtures | x | x | x
Criterion 5.4 — Substances listed in accordance with Article 59(1) of Regulation (EC) No 1907/2006 | x | x | x
Criterion 5.5 — Limits forE. coliandSalmonellaspp. | x | x | x
Criterion 6 — Stability | x | x | x
Criterion 7 — Physical contaminants | x | x | x
Criterion 8 — Organic matter and dry matter | | x | x
Criterion 9 — Viable weed seeds and plant propagules | x | x |
Criterion 10 — Plant response | x | x |
Criterion 11 — Growing media features | x | |
Criterion 12 — Provision of information | x | x | x
Criterion 13 — Information appearing on the EU Ecolabel | x | x | xASSESSMENT AND VERIFICATION REQUIREMENTSThe specific assessment and verification requirements are indicated within each criterion.
Where the applicant is required to provide declarations, documentation, analyses, test reports, or other evidence to show compliance with the criteria, these may originate from the applicant and/or their supplier(s) as appropriate.
Competent Bodies shall preferentially recognise attestations which are issued by bodies accredited according to the relevant harmonised standard for testing and calibration laboratories and verifications by bodies that are accredited according to the relevant harmonised standard for bodies certifying products, processes and services.
Where appropriate, test methods other than those indicated for each criterion may be used if the Competent Body assessing the application accepts their equivalence.
Where appropriate, Competent Bodies may require supporting documentation and may carry out independent verifications.
As pre-requisite, the product must meet all respective legal requirements of the country (countries) in which the product is intended to be placed on the market. The applicant shall declare the product’s compliance with this requirement.
The sampling shall be carried out according to EN 12579 (Soil improvers and growing media. Sampling). Samples shall be prepared according to EN 13040 (Soil improvers and growing media. Sample preparation for chemical and physical tests, determination of dry matter content, moisture content and laboratory compacted bulk density).
For the application year, the sampling and test frequency shall fulfil the requirements set in Appendix 1. For the following years, the sampling and test frequency of final products shall fulfil the requirements set in Appendix 2. Different sampling and testing frequencies are set for the following types of plants:

— | Type 1 | : | Treatment plants for waste or for animal by-products
— | Type 2 | : | Product manufacture plants using materials from Type 1 plants
— | Type 3 | : | Product manufacture plants not using materials derived from waste or from animal by-products.For Type 2 plants, the sampling and test frequencies for the application year and the following years will be the same as the frequencies set for Type 3, if their waste/animal by-product-derived materials’ suppliers comply with the EU Ecolabel criteria for soil improvers. The applicant shall provide the Competent Body with the test reports from the suppliers, together with the documentation to ensure the compliance of the suppliers with the EU Ecolabel criteria. The Competent Body may recognize the sampling and testing frequencies within the national or regional legislation and standards as valid to ensure the compliance with the EU Ecolabel criteria of the suppliers of waste or animal by-products derived materials. In case when a product constitutes or contains material of animal origin reference shall be done to microbiological standards and animal and public health controls set out in Commission Regulation (EU) No 142/2011(2).

Criterion 1 — Constituents
This criterion applies to growing media, soil improvers and mulch.
The constituents admitted shall be organic and/or mineral constituents.
Assessment and verification:
The applicant shall provide the Competent Body with a list of constituents of the product.

Criterion 2 — Organic constituents
This criterion applies to growing media, soil improvers and mulch.

Criterion 2.1. A final product shall not contain peat.

Criterion 2.2.
(1) | The following materials are allowed as organic constituents of a final product.—Materials derived from the recycling of bio-waste from separate collection, as defined in Article 3 of Directive 2008/98/EC of the European Parliament and of the Council(3).—Materials derived from category 2 and 3 animal by-products as laid down in Article 32 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council(4)and technical standards which are laid down by implementing Regulation (EU) 142/2011.—Materials derived from faecal matter, straw and other natural non-hazardous agricultural or forestry material as defined in Article 2(1)(f) of Directive 2008/98/EC.—Materials derived from any other biomass by-products, as defined in Article 5 of Directive 2008/98/EC, that are not mentioned above, subject to the provisions of (2) and sub-criterion 2.3.—Materials derived from recycling or recovery of any other biomass waste not mentioned above, subject to the provisions of (2) and sub-criterion 2.3. | — | Materials derived from the recycling of bio-waste from separate collection, as defined in Article 3 of Directive 2008/98/EC of the European Parliament and of the Council(3). | — | Materials derived from category 2 and 3 animal by-products as laid down in Article 32 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council(4)and technical standards which are laid down by implementing Regulation (EU) 142/2011. | — | Materials derived from faecal matter, straw and other natural non-hazardous agricultural or forestry material as defined in Article 2(1)(f) of Directive 2008/98/EC. | — | Materials derived from any other biomass by-products, as defined in Article 5 of Directive 2008/98/EC, that are not mentioned above, subject to the provisions of (2) and sub-criterion 2.3. | — | Materials derived from recycling or recovery of any other biomass waste not mentioned above, subject to the provisions of (2) and sub-criterion 2.3.
— | Materials derived from the recycling of bio-waste from separate collection, as defined in Article 3 of Directive 2008/98/EC of the European Parliament and of the Council(3).
— | Materials derived from category 2 and 3 animal by-products as laid down in Article 32 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council(4)and technical standards which are laid down by implementing Regulation (EU) 142/2011.
— | Materials derived from faecal matter, straw and other natural non-hazardous agricultural or forestry material as defined in Article 2(1)(f) of Directive 2008/98/EC.
— | Materials derived from any other biomass by-products, as defined in Article 5 of Directive 2008/98/EC, that are not mentioned above, subject to the provisions of (2) and sub-criterion 2.3.
— | Materials derived from recycling or recovery of any other biomass waste not mentioned above, subject to the provisions of (2) and sub-criterion 2.3.
(2) | The following materials are not allowed as organic constituents of a final product.—Materials totally or partially derived from the organic fraction of mixed municipal household waste separated through mechanical, physicochemical, biological and/or manual treatment.—Materials totally or partially derived from sludges derived from municipal sewage water treatment and from sludges derived from the paper industry.—Materials totally or partially derived from sludges other than those allowed in Criterion 2.3.—Materials totally or partially derived from category 1 animal by-products according to Regulation (EC) No 1069/2009. | — | Materials totally or partially derived from the organic fraction of mixed municipal household waste separated through mechanical, physicochemical, biological and/or manual treatment. | — | Materials totally or partially derived from sludges derived from municipal sewage water treatment and from sludges derived from the paper industry. | — | Materials totally or partially derived from sludges other than those allowed in Criterion 2.3. | — | Materials totally or partially derived from category 1 animal by-products according to Regulation (EC) No 1069/2009.
— | Materials totally or partially derived from the organic fraction of mixed municipal household waste separated through mechanical, physicochemical, biological and/or manual treatment.
— | Materials totally or partially derived from sludges derived from municipal sewage water treatment and from sludges derived from the paper industry.
— | Materials totally or partially derived from sludges other than those allowed in Criterion 2.3.
— | Materials totally or partially derived from category 1 animal by-products according to Regulation (EC) No 1069/2009.
Criterion 2.3. Materials derived from recycling or recovery of sludges are only allowed if the sludges comply with the following requirements:

(a) | they are identified as one of the following types of waste according to the European List of Wastes, as defined by Commission Decision 2000/532/EC(5)presented in Table 2:Table 2Sludges allowed and their codes according to the European List of Wastes0203 05sludges from on-site effluent treatment in the preparation and processing of fruit, vegetables, cereals, edible oils, cocoa, coffee, tea and tobacco, conserve production, yeast and yeast extract production, molasses preparation and fermentation;0204 03sludges from on-site effluent treatment in sugar processing;0205 02sludges from on-site effluent treatment in the dairy products industry;0206 03sludges from on-site effluent treatment in the baking and confectionery industry;0207 05sludges from on-site effluent treatment in the production of alcoholic and non-alcoholic beverages (except coffee, tea and cocoa). | 0203 05 | sludges from on-site effluent treatment in the preparation and processing of fruit, vegetables, cereals, edible oils, cocoa, coffee, tea and tobacco, conserve production, yeast and yeast extract production, molasses preparation and fermentation; | 0204 03 | sludges from on-site effluent treatment in sugar processing; | 0205 02 | sludges from on-site effluent treatment in the dairy products industry; | 0206 03 | sludges from on-site effluent treatment in the baking and confectionery industry; | 0207 05 | sludges from on-site effluent treatment in the production of alcoholic and non-alcoholic beverages (except coffee, tea and cocoa).
0203 05 | sludges from on-site effluent treatment in the preparation and processing of fruit, vegetables, cereals, edible oils, cocoa, coffee, tea and tobacco, conserve production, yeast and yeast extract production, molasses preparation and fermentation;
0204 03 | sludges from on-site effluent treatment in sugar processing;
0205 02 | sludges from on-site effluent treatment in the dairy products industry;
0206 03 | sludges from on-site effluent treatment in the baking and confectionery industry;
0207 05 | sludges from on-site effluent treatment in the production of alcoholic and non-alcoholic beverages (except coffee, tea and cocoa).
(b) | they are single-source separated, meaning that there has been no mixing with effluents or sludges outside a specific production process.Assessment and verification:
The applicant shall provide the Competent Body with the information about the origin of each organic constituent of the product and a declaration of compliance with the above requirement.

Criterion 3 — Mineral growing media and mineral constituents

Criterion 3.1. Energy consumption and CO2 emissions
This criterion applies to mineral growing media only.
The manufacture of expanded minerals and mineral wool shall fulfil the following energy consumption and CO2emissions thresholds:

— | Energy consumption/product ≤ 11 GJ/t product
— | CO2emissions/product ≤ 0,8 t CO2/t productThe ratio energy consumption/product shall be calculated as an annual average as follows:

Where:

— | nis the number of years of the period used to calculate the average
— | iis each year of the period used to calculate the average
— | Productionis the production of mineral wool or expanded minerals in tonnes in the yeari
— | Fis the annual consumption of fuels in the production process in the yeari
— | Elgridis the annual electricity consumption from the grid in the yeari
— | Hcogis the annual consumption of useful heat from cogeneration in the yeari
— | Elcogis the annual consumption of electricity from cogeneration in the yeari
— | Ref HηandRef Eηare the reference efficiencies for the separate production of heat and electricity as defined in the Directive 2012/27/EU of the European Parliament and of the Council(6)and calculated according to the Commission Implementing Decision 2011/877/EU(7)
— | PEScogis the primary energy saving of the cogeneration plant as defined in the Directive 2012/27/EU, in the yeariThe ratio CO2emissions/product shall be calculated as an annual average as follows:

Where:

— | nis the number of years of the period used to calculate the average
— | iis each year of the period used to calculate the average
— | Productionis the mineral wool production in tonnes in the yeari
— | Direct CO2is the CO2emissions as defined in Commission Regulation (EU) No 601/2012(8), in the yeari
— | Indirect CO2is the indirect CO2emissions due to final energy consumption in the yeari, and shall be calculated as:
Where:

— | FEgridis the EU average carbon intensity of the electricity grid, according to MEErP(9)methodology (0,384 tCO2/MWhe = 0,107 tCO2/GJe)
— | FEfuel cogis the CO2emission factor of the fuel consumed in the cogeneration plantThe direct CO2emissions shall be monitored according to Regulation (EU) No 601/2012.
The period to calculate the ratios energy consumption/product and CO2emissions/product shall be the last 5 years before the application. If the operation period of the plant is less than 5 years at the date of application, the ratio shall be calculated as an annual average of that operation period, which shall be at least 1 year.
Assessment and verification:
The applicant shall provide the Competent Body with a declaration which includes the following information.

— | Ratio energy consumption (GJ)/product (tonne).
— | Ratio CO2emissions (tonne)/product (tonne).
— | Direct CO2emissions (tonnes) for each year of the period to calculate the average.
— | Indirect CO2emissions (tonnes) for each year of the period to calculate the average.
— | Fuels consumed, consumption of each fuel (GJ), sub-process/es of the manufacture process where they are consumed for each year of the period to calculate the average.
— | Electricity consumption from the grid (GJ final energy) for each year of the period to calculate the average.
— | Useful heat consumption from cogeneration (GJ final energy) for each year of the period to calculate the average.
— | Electricity consumption from cogeneration (GJ final energy) for each year of the period to calculate the average.
— | Reference efficiencies for separate production of heat and electricity.
— | Primary energy saving (PES) (%) of the cogeneration for each year of the period to calculate the average.
— | Identification of fuels used in cogeneration and their share in the fuel mix, for each year of the period to calculate the average.The following documents shall be provided together with the declarations.

— | Annual emissions report according to Regulation (EU) No 601/2012, for each year of the period to calculate the average.
— | Verification report finding the annual emissions report satisfactory according to Commission Regulation (EU) No 600/2012(10), for each year of the period to calculate the average.
— | Records of electricity consumption from the grid provided by the supplier, for each year of the period to calculate the average.
— | Records of the useful heat and electricity consumption from cogeneration, both on-site and purchased, for each year of the period to calculate the average.
Criterion 3.2. Sources of mineral extraction
This criterion applies to growing media, soil improvers and mulch.
Extracted minerals can be used as constituents of the final product provided that:

(1) | (Within the EU): If they are extracted from Natura 2000 network areas, composed of Special Protection Areas under Directive 2009/147/EC of the European Parliament and of the Council(11)on the conservation of wild birds, and Special Areas of Conservation under Council Directive 92/43/EEC(12)on the conservation of natural habitats and wild fauna and flora, extraction activities have been assessed and authorised in accordance with the provisions of Article 6 of Directive 92/43/EEC and taking into account the EC Guidance document on non-energy mineral extraction and Natura 2000(13);
(2) | (Outside the EU): If they are extracted from protected areas designated as such under the national legislation of the sourcing/exporting countries, the extraction activities have been assessed and authorised in accordance with provisions that provide assurances equivalent to those under (1).Assessment and verification
In case mineral extraction activities have been carried out in Natura 2000 network areas (in the EU) or protected areas designated as such under the national legislation of the sourcing/exporting countries (outside the EU), the applicant shall provide a declaration of compliance with this requirement issued by the competent authorities or a copy of their authorisation issued by the competent authorities.

Criterion 3.3. Mineral growing media use and after use
This criterion is applicable to mineral growing media only.
The mineral growing media shall only be offered for use for professional horticultural applications.
The applicant shall offer customers a structured collection and recycling service, which may use third party service providers. The collection and recycling service shall cover a minimum of 70 % v/v of the applicant’s sales of the product across the European Union.
Assessment and verification:
The applicant shall provide the Competent Body with a declaration that the mineral growing media is only offered for use in professional horticultural applications. A statement about the professional horticultural application of the product shall be included in the information provided to the end-user.
The applicant shall inform the Competent Body about the option(s) on offer of structured collection and recycling service and the results of the option(s) implemented. In particular, the applicant shall provide the following documentation and information.

— | Contract documentation between the manufacturer and the service providers.
— | Description of collection, processing and destinations.
— | Annual overview of the total sales volume of growing media in the European Union Member States and an annual overview of the sales volumes in areas of those Member States where collection and processing are on offer.
— | In case of new entrants, an estimation of the annual overview of the total sales volume of growing media in the European Union Member States and an estimation of the annual overview of the sales volumes in areas of those Member States where collection and processing are on offer, shall be provided. Real data shall be provided 1 year after the EU Ecolabel license is awarded.
Criterion 4 — Recycled/recovered and organic materials in growing media
This criterion applies to growing media only.
Growing media products shall contain a minimum percentage of recycled/recovered content or organic content, as follows:

(a) | The growing medium shall contain a minimum of 30 % of organic constituents (expressed as volume of organic constituent per total volume of the final product); or
(b) | The mineral growing medium shall contain mineral constituents manufactured from a process using at least 30 % of recycled materials (expressed as the dry weight of recycled/recovered materials per total dry weight of the input materials).Assessment and verification:
The applicant shall declare the following information:

— | for the case (a): volume of organic constituents declared in Criterion 1 per total volume of the final product, or
— | for the case (b): dry weight of recycled/recovered materials per total dry weight of the input materials.For the case (b), the applicant shall also declare the following information about the mineral constituents:

— | identification of raw material inputs, dry weight of the raw material input per total dry weight of the input materials, and origin, for each raw material input, and
— | identification of recycled/recovered material inputs, dry weight of recycled/recovered material input per total dry weight of the input materials and origin, for each recycled/recovered material input.
Criterion 5 — Limitation of hazardous substances

Criterion 5.1. — Limits for heavy metals
This criterion applies to growing media, soil improvers and mulch.
(a) Soil improvers, mulch and organic constituents of growing mediaFor soil improvers, mulch and organic constituents of growing media, the content of the following elements in the final product or constituent shall not exceed the values shown in Table 3, measured in terms of dry weight (DW) of the product.

Table 3

Heavy metals limits for soil improvers, mulch and organic constituents of growing media

Heavy metal | Maximum content in the product (mg/kg DW)
Cadmium (Cd) | 1
Chromium total (Cr) | 100
Copper (Cu) | 100
Mercury (Hg) | 1
Nickel (Ni) | 50
Lead (Pb) | 100
Zinc (Zn) | 300(b) Growing mediaFor growing media, including mineral growing media, the content of the following elements in the final product shall not exceed the values shown in Table 4, measured in terms of dry weight of the product.

Table 4

Heavy metal limits for growing media, including mineral growing media

Heavy metal | Maximum content in the product (mg/kg DW)
Cadmium (Cd) | 3
Chromium total (Cr) | 150
Copper (Cu) | 100
Mercury (Hg) | 1
Nickel (Ni) | 90
Lead (Pb) | 150
Zinc (Zn) | 300Assessment and verification:
The applicant shall provide the Competent Body with test reports conducted in accordance with the testing procedure indicated in the respective EN standards presented in Table 5. In the case of organic constituents of growing media, the test reports may be provided by the suppliers.

Table 5

Standard methods of extraction and measurement of heavy metals

Heavy metals | Method of measurement | Method of extraction
Cadmium (Cd) | EN 13650 | For soil improvers, mulch, organic constituents of growing media and growing media, except mineral growing media:EN 13650 Soil improvers and growing media — Extraction of aqua regia soluble elementsFor mineral growing media:EN 13651 Soil improvers and growing media — Extraction of calcium chloride/DTPA (CAT) soluble nutrients and elements
Chromium total (Cr) | EN 13650
Copper (Cu) | EN 13650
Mercury (Hg) | EN 16175(14)
Nickel (Ni) | EN 13650
Lead (Pb) | EN 13650
Zinc (Zn) | EN 13650
Criterion 5.2. — Limits for Polycyclic Aromatic Hydrocarbons (PAH)
This criterion applies to growing media, soil improvers and mulch, with the exception of mineral growing media.
The content of the following polycyclic aromatic hydrocarbons in the final product shall not exceed the value shown in Table 6, measured in terms of dry weight of the product.

Table 6

Limit for PAH

Pollutant | Maximum content in the product (mg/kg DW)
PAH16 | 6
PAH16= sum of naphthalene, acenaphtylene, acenaphtene, fluorene, phenanthrene, anthracene, fluoranthene, pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, indeno[1,2,3-cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]peryleneAssessment and verification:
The applicant shall provide the Competent Body with test reports conducted in accordance with the testing procedure indicated in CEN/TS 16181 Sludge, treated biowaste and soil — Determination of polycyclic aromatic hydrocarbons (PAH) by gas chromatography (GC) and high performance liquid chromatography (HPLC) or equivalent.

Criterion 5.3. — Hazardous substances and mixtures
This criterion applies to growing media, soil improvers and mulch.
The final product shall not be classified and labelled as being acutely toxic, a specific target organ toxicant, a respiratory or skin sensitiser, or carcinogenic, mutagenic or toxic for reproduction hazardous to the environment, in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council(15).
The product shall not contain substances or mixtures classified as toxic, hazardous to the environment, respiratory or skin sensitisers, or carcinogenic, mutagenic or toxic for reproduction in accordance with Regulation (EC) No 1272/2008 and as interpreted according to the hazard statements listed in Table 7. Any intentionally added ingredient present at a concentration above 0,010 % w/w (in terms of wet weight) in the product shall meet this requirement. Where stricter, the generic or specific concentration limits determined in accordance with Article 10 of Regulation (EC) No 1272/2008 shall prevail to the cut-off limit value of 0,010 % w/w (in terms of wet weight) mentioned above.

Table 7

Restricted hazard classifications and their categorisation

Acute toxicity
Category 1 and 2 | Category 3
H300 Fatal if swallowed | H301 Toxic if swallowed
H310 Fatal in contact with skin | H311 Toxic in contact with skin
H330 Fatal if inhaled | H331 Toxic if inhaled
H304 May be fatal if swallowed and enters airways | EUH070 Toxic by eye contact
Specific target organ toxicity
Category 1 | Category 2
H370 Causes damage to organs | H371 May cause damage to organs
H372 Causes damage to organs through prolonged or repeated exposure | H373 May cause damage to organs through prolonged or repeated exposure
Respiratory and skin sensitisation
Category 1A | Category 1B
H317: May cause allergic skin reaction | H317: May cause allergic skin reaction
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled | H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled
Carcinogenic, mutagenic or toxic for reproduction
Category 1A and 1B | Category 2
H340 May cause genetic defects | H341 Suspected of causing genetic defects
H350 May cause cancer | H351 Suspected of causing cancer
H350i May cause cancer by inhalation |
H360F May damage fertility | H361f Suspected of damaging fertility
H360D May damage the unborn child | H361d Suspected of damaging the unborn child
H360FD May damage fertility. May damage the unborn child | H361fd Suspected of damaging fertility. Suspected of damaging the unborn child
H360Fd May damage fertility. Suspected of damaging the unborn child | H362 May cause harm to breast fed children
H360Df May damage the unborn child. Suspected of damaging fertility |
Hazardous to the aquatic environment
Category 1 and 2 | Category 3 and 4
H400 Very toxic to aquatic life | H412 Harmful to aquatic life with long-lasting effects
H410 Very toxic to aquatic life with long-lasting effects | H413 May cause long-lasting effects to aquatic life
H411 Toxic to aquatic life with long-lasting effects |
Hazardous to the ozone layer
H420 Hazardous to the ozone layer | The most recent classification rules adopted by the Union shall take precedence over the listed hazard classifications. In accordance with Article 15 of Regulation (EC) No 1272/2008, applicants shall therefore ensure that any classifications are based on the most recent rules on classification, labelling and packaging of substances and mixtures.
The hazard statements generally refer to substances. However, if information on substances cannot be obtained, the classification rules for mixtures shall apply.
Substances or mixtures which change their properties through processing and thus become no longer bioavailable or undergo chemical modification in a way that removes the previously identified hazard are exempted from criterion 5.3.
This criterion does not apply to those final products composed by:

— | Materials not included in the scope of the Regulation (EC) No 1907/2006 according its Article 2(2).
— | Substances covered by Article 2(7)(b) of the Regulation (EC) No 1907/2006,which sets out criteria for exempting substances within Annex V to that Regulation from the registration, downstream user and evaluation requirements.In order to determine if this exclusion applies, the applicant shall screen any intentionally added substance present at a concentration above 0,010 % w/w (in terms of wet weight).
Assessment and verification:
The applicant shall screen the presence of substances and mixtures that may be classified with the hazard statements reported in this criterion. The applicant shall provide the Competent Body with a declaration of compliance with this criterion for the product.
That declaration shall include related documentation, such as declarations of compliance signed by the suppliers, on the non-classification of the substances, mixtures or materials with any of the hazard classes associated to the hazard statements referred in Table 7 in accordance with Regulation (EC) No 1272/2008, as far as this can be determined, as a minimum, from the information meeting the requirements listed in Annex VII to Regulation (EC) No 1907/2006.
The information provided shall relate to the forms or physical states of the substances or mixtures as used in the final product.
The following technical information shall be provided to support the declaration of classification or non-classification for each substance and mixture:

(i) | for substances that have not been registered under Regulation (EC) No 1907/2006 or which do not yet have a harmonised CLP classification: information meeting the requirements listed in Annex VII to that Regulation;
(ii) | for substances that have been registered under Regulation (EC) No 1907/2006 and which do not meet the requirements for CLP classification: information based on the REACH registration dossier confirming the non-classified status of the substance;
(iii) | for substances that have a harmonised classification or are self-classified: safety data sheets where available. If these are not available or the substance is self-classified then information shall be provided relevant to the substances hazard classification in accordance with Annex II to Regulation (EC) No 1907/2006;
(iv) | in the case of mixtures: safety data sheets where available. If these are not available then calculation of the mixture classification shall be provided according to the rules under Regulation (EC) No 1272/2008 together with information relevant to the mixtures hazard classification in accordance with Annex II to Regulation (EC) No 1907/2006.Safety data sheets shall be provided for the materials composing the final product and for substances and mixtures used in the formulation and treatment of the materials remaining in the final product at a concentration above a cut-off limit of 0,010 % w/w (in terms of wet weight) unless a lower generic or specific concentration limit applies in accordance with the Article 10 of Regulation (EC) No 1272/2008.
Safety data sheets shall be completed in accordance with the guidance set out in sections 10, 11 and 12 of Annex II to Regulation (EC) No 1907/2006 (requirements for the compilation of safety data sheets). Incomplete safety data sheets shall require supplementing with information from declarations by chemical suppliers.
Information on intrinsic properties of substances may be generated by means other than tests, for instance through the use of alternative methods such as in vitro methods, by quantitative structure activity models or by the use of grouping or read-across in accordance with Annex XI to Regulation (EC) No 1907/2006.
The sharing of relevant data across the supply chain is strongly encouraged.
In the case of mineral wool, the applicant shall also provide the following:

(a) | Certificate awarded for the right to use the European Certification Board for Mineral Wool Products trademark to demonstrate compliance with the Note Q within the Regulation (EC) No 1272/2008.
(b) | Test report according to ISO 14184-1 Textiles — Determination of formaldehyde — Part 1: Free and hydrolysed formaldehyde.
Criterion 5.4. — Substances listed in accordance with Article 59(1) of Regulation (EC) No 1907/2006
The final product shall not contain any intentionally added substances of very high concern and included in the list provided for in Article 59(1) of Regulation (EC) No 1907/2006, present in the final product in concentrations > 0,010 % in terms of wet weight.
Assessment and verification:
Reference to the latest list of substances of very high concern shall be made on the date of application. The applicant shall provide a declaration of compliance with criterion 5.4, together with related documentation, including declarations of compliance signed by the material suppliers and copies of relevant SDS for substances or mixtures in accordance with Annex II to Regulation (EC) No 1907/2006 for substances or mixtures. Concentration limits shall be specified in the safety data sheets in accordance with Article 31 of Regulation (EC) No 1907/2006 for substances and mixtures.

Criterion 5.5. — Limits for E. coli and Salmonella spp.
This criterion applies to growing media, soil improvers and mulch, with the exception of mineral growing media.
The content of primary pathogens in the final product shall not exceed the levels set in Table 8.

Table 8

Limit values for E. coli and Salmonella spp.

Pathogen | Limit
E. coli | 1 000 CFU/g fresh weight
Salmonellaspp. | absent in 25 g fresh weight
CFU= colony-forming units.Assessment and verification:
The applicant shall provide the Competent Body with test reports conducted in accordance with the testing procedure indicated in Table 9.

Table 9

Standard test method for E. coli and Salmonella spp.

Parameter | Test method
E. coli | CEN/TR 16193 Sludge, treated biowaste and soil. Detection and enumeration ofEscherichia colior equivalent
Salmonellaspp. | ISO 6579 Microbiology of food and animal feeding stuffs — Horizontal method for the detection ofSalmonellaspp.
Criterion 6 — Stability
This criterion applies to growing media, soil improvers and mulch, with the exception of mulch totally composed of lignocellulosic constituents and mineral growing media.
Soil improvers and mulch for non-professional applications and growing media for all applications shall meet one of the requirements presented in Table 10.

Table 10

Stability requirements of soil improvers and mulch intended for non-professional applications and growing media intended for all applications

Stability parameter | Requirement
Maximum Respirometric index | 15 mmol O2/kg organic matter/h
Minimum Rottegrad, where applicable | IV (self-heating test temperature rise of maximum 20 °C above ambient temperature)Soil improvers and mulch for professional applications shall meet one of the requirements presented in Table 11.

Table 11

Stability requirements of soil improvers and mulch intended for professional applications

Stability parameter | Requirement
Maximum Respirometric index | 25 mmol O2/kg organic matter/h
Minimum Rottegrad, where applicable | III (self-heating test temperature rise of maximum 30 °C above ambient temperature)Assessment and verification:
The applicant shall provide the Competent Body with test reports conducted in accordance with the testing procedure indicated in Table 12.

Table 12

Standard test method for stability

Parameter | Test method
Respirometric index | EN 16087-1 Soil improvers and growing media — Determination of the aerobic biological activity. Oxygen uptake rate (OUR)
Rottegrad | EN 16087-2 Soil improvers and growing media. Determination of the aerobic biological activity. Self-heating test for compost
Criterion 7 — Physical Contaminants
This criterion applies to growing media, soil improvers and mulch, with the exception of mineral growing media.
The content of glass, metal and plastic with mesh size of > 2 mm in the final product shall not exceed 0,5 %, measured in terms of dry weight.
Assessment and verification:
The applicant shall provide the Competent Body with test reports conducted in accordance with the testing procedure indicated in the Technical Specification CEN/TS 16202 (Sludge, treated biowaste and soil — Determination of impurities and stones), or another equivalent testing procedure authorised by the Competent Body.

Criterion 8 — Organic matter and dry matter
This criterion applies to soil improvers and mulch.
The organic matter as loss on ignition of the final product shall be at least 15 % dry weight (% DW).
The dry matter content of the final product shall be at least 25 % of the fresh weight (% FW).
Assessment and verification:
The applicant shall provide the Competent Body with test reports conducted in accordance with the testing procedure presented in Table 13.

Table 13

Standard test methods for Dry matter and Organic matter

Parameter | Test method
Dry matter (% FW) | EN 13040 Soil improvers and growing media. Sample preparation for chemical and physical tests, determination of dry matter content, moisture content and laboratory compacted bulk density
Organic matter as Loss on Ignition (% DM) | EN 13039 Soil improvers and growing media. Determination of organic matter content and ash
Criterion 9 — Viable weed seeds and plant propagules
This criterion applies to growing media and soil improvers, with the exception of mineral growing media.
Final products shall not contain more than two units of viable weed seeds and plant propagules per litre.
Assessment and verification:
The applicant shall provide the Competent Body with a test report in accordance with the testing procedure indicated in the Technical Specification CEN/TS 16201 (Sludge, treated biowaste and soil — Determination of viable plant seeds and propagules), or another equivalent testing procedure authorised by the Competent Body.

Criterion 10 — Plant response
This criterion applies to growing media and soil improvers.
Final products shall not adversely affect plant emergence or subsequent growth.
Assessment and verification:
The applicant shall provide the Competent Body with a valid test conducted in accordance with the testing procedure indicated in EN 16086-1 (Soil improvers and growing media — Determination of plant response — Part 1: Pot growth test with Chinese cabbage).

Criterion 11 — Growing media features
This criterion only applies to growing media.

Criterion 11.1. — Electrical conductivity
The electrical conductivity of the final product shall be below 100 mS/m.
Assessment and verification:
The applicant shall provide the Competent Body with a test report conducted in accordance with the testing procedure indicated in EN 13038 (Soil improvers and growing media — Determination of electrical conductivity).

Criterion 11.2. — pH
The pH of the final product shall be in the range 4-7.
Assessment and verification:
The applicant shall provide the Competent Body with a test report conducted in accordance with the testing procedure indicated in EN 13037 (Soil improvers and growing media — Determination of pH).

Criterion 11.3. — Sodium content
The sodium content in water extracts of the final product shall not exceed 150 mg/l of fresh product.
Assessment and verification:
The applicant shall provide the Competent Body with a test report conducted in accordance with the testing procedure indicated in EN 13652 (Soil improvers and growing media — Extraction of water soluble nutrients and elements).

Criterion 11.4. — Chloride content
The chloride content in water extracts of the final product shall not exceed 500 mg/l of fresh product.
Assessment and verification:
The applicant shall provide the Competent Body with a test report conducted in accordance with the testing procedure indicated in EN 13652 (Soil improvers and growing media — Extraction of water soluble nutrients and elements).

Criterion 12 — Provision of information
This criterion applies to growing media, soil improvers and mulch.
The following information shall be provided with the product either on the packaging or in accompanying fact sheets.

Criterion 12.1. — Soil improvers

(a) | The name and address of the body responsible for marketing;
(b) | A descriptor identifying the product by type, including the wording ‘SOIL IMPROVER’;
(c) | A batch identification code;
(d) | The quantity (in weight);
(e) | Range of moisture content;
(f) | The main materials (those over 5 % by weight) from which the product has been manufactured;
(g) | The recommended conditions of storage and the recommended ‘use by’ date;
(h) | Guidelines for safe handling and use;
(i) | A description of the purpose for which the product is intended and any limitations on use, including a statement about the suitability of the product for particular plant groups (e.g. calcifuges or calcicoles);
(j) | pH (reference of the test method used);
(k) | Organic carbon content (%), total nitrogen content (%) and inorganic nitrogen content (%) (reference to the test method used);
(l) | Carbon/Nitrogen ratio;
(m) | Total phosphorus (%) and total potassium (%) (reference to the test method used);
(n) | For products for non-professional use, a statement about the stability of organic matter (stable or very stable);
(o) | A statement on recommended methods of use;
(p) | In non-professional applications: recommended rate of application expressed in kilograms of product per unit surface area (m2) per annum.
Criterion 12.2. — Growing media

(a) | The name and address of the body responsible for marketing;
(b) | A descriptor identifying the product by type, including the wording ‘GROWING MEDIUM’;
(c) | A batch identification code;
(d) | The quantity (in volume or number of slabs, in case of mineral wool, specifying the dimensions of the slab);
(e) | Range of moisture content;
(f) | The main materials (those over 5 % by volume) from which the product has been manufactured;
(g) | The recommended conditions of storage and the recommended ‘use by’ date;
(h) | Guidelines for safe handling and use;
(i) | A description of the purpose for which the product is intended and any limitations on use, including a statement about the suitability of the product for particular plant groups (e.g. calcifuges or calcicoles);
(j) | pH (EN 13037);
(k) | Electrical Conductivity (1:5 extraction);
(l) | Germination inhibition (EN 16086-1);
(m) | Growth inhibition (EN 16086-1);
(n) | A statement about the stability of organic matter (stable or very stable);
(o) | A statement on recommended methods of use;
(p) | For mineral growing media, a statement about the professional horticultural application.
Criterion 12.3. — Mulch

(a) | The name and address of the body responsible for marketing;
(b) | A descriptor identifying the product by type, including the wording ‘MULCH’;
(c) | A batch identification code;
(d) | The quantity (in volume);
(e) | Range of moisture content;
(f) | The main materials (those over 5 % by volume) from which the product has been manufactured;
(g) | Guidelines for safe handling and use;
(h) | A description of the purpose for which the product is intended and any limitations on use, including a statement about the suitability of the product for particular plant groups (e.g. calcifuges or calcicoles);
(i) | pH (reference of the test method used);
(j) | A statement about the stability of organic matter (stable or very stable), where applicable, for non-professional uses;
(k) | A statement on recommended methods of use;
(l) | In non-professional applications: recommended rate of application expressed in mm.Assessment and verification:
The applicant shall declare that the product complies with this criterion and provide the Competent Body with a sample of the packaging or fact sheets or the text of the user information written on the packaging or accompanying fact sheets.

Criterion 13 — Information appearing on the EU Ecolabel
The optional label with text box shall contain the following text:

— | promotes the recycling of materials
— | promotes the use of renewable and recycled materialsFor soil improvers and mulch, the additional information shall be included:

— | reduces soil and water pollution, by limiting heavy metals concentrationsThe guidelines for the use of the optional label with the text box can be found in the ‘Guidelines for the use of the EU Ecolabel logo’ on the website:
http://ec.europa.eu/environment/ecolabel/documents/logo_guidelines.pdf
Assessment and verification:
The applicant shall provide the Competent Body with a sample of the product packaging showing the label, together with a declaration of compliance with this criterion.

(1) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
(2) Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1).
(3) Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).
(4) Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1).
(5) Commission Decision 2000/532/EC of 3 May 2000 replacing Decision 94/3/EC establishing a list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on waste and Council Decision 94/904/EC establishing a list of hazardous waste pursuant to Article 1(4) of Council Directive 91/689/EEC on hazardous waste (OJ L 226, 6.9.2000, p. 3).
(6) Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC (OJ L 315, 14.11.2012, p. 1).
(7) Commission Implementing Decision 2011/877/EU of 19 December 2011 establishing harmonised efficiency reference values for separate production of electricity and heat in application of Directive 2004/8/EC of the European Parliament and of the Council and repealing Commission Decision 2007/74/EC (OJ L 343, 23.12.2011, p. 91).
(8) Commission Regulation (EU) No 601/2012 of 21 June 2012 on the monitoring and reporting of greenhouse gas emissions pursuant to Directive 2003/87/EC of the European Parliament and of the Council (OJ L 181, 12.7.2012, p. 30).
(9) Methodology for the Ecodesign of Energy-related Products (http://www.meerp.eu/).
(10) Commission Regulation (EU) No 600/2012 of 21 June 2012 on the verification of greenhouse gas emission reports and tonne-kilometre reports and the accreditation of verifiers pursuant to Directive 2003/87/EC of the European Parliament and of the Council (OJ L 181, 12.7.2012, p. 1).
(11) Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7).
(12) Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7).
(13) EC Guidance on undertaking new non-energy extractive activities in accordance with Natura 2000 requirements (http://ec.europa.eu/environment/nature/natura2000/management/docs/neei_n2000_guidance.pdf).
(14) EN 16175 Sludge, treated biowaste and soil — Determination of mercury. Part 1: Cold-vapour atomic absorption spectrometry (CV-AAS) and Part 2: Cold-vapour atomic fluorescence spectrometry (CV-AFS.)
(15) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

Sampling and test frequency for the application year

Appendix 1
Type of plant | Criterion | Annual input/output | Test frequency
Type 1: Treatment plants for waste or for animal by-products | 5.1—Limits for heavy metals5.5—Limits forE. coliandSalmonellaspp.6—Stability7—Physical contaminants8—Organic matter and dry matter9—Viable seeds and plant propagules10—Plant response11—Growing media features | 5.1 | — | Limits for heavy metals | 5.5 | — | Limits forE. coliandSalmonellaspp. | 6 | — | Stability | 7 | — | Physical contaminants | 8 | — | Organic matter and dry matter | 9 | — | Viable seeds and plant propagules | 10 | — | Plant response | 11 | — | Growing media features | Input (t) ≤ 3 000 | 1 every 1 000 tonnes input material rounded to the next integer
5.1 | — | Limits for heavy metals
5.5 | — | Limits forE. coliandSalmonellaspp.
6 | — | Stability
7 | — | Physical contaminants
8 | — | Organic matter and dry matter
9 | — | Viable seeds and plant propagules
10 | — | Plant response
11 | — | Growing media features
3 000 < input (t) ≤ 20 000 | 4 (one sample every season)
Input (t) > 20 000 | number of analyses per year = amount of annual input material (in tonnes)/10 000 tonne + 1Minimum 4 and maximum 12
5.2—PAH | 5.2 | — | PAH | Input (t) ≤ 3 000 | 1
5.2 | — | PAH
3 000 < input (t) ≤ 10 000 | 2
10 000 < input (t) ≤ 20 000 | 3
20 000 < input (t) ≤ 40 000 | 4
40 000 < input (t) ≤ 60 000 | 5
60 000 < input (t) ≤ 80 000 | 6
80 000 < input (t) ≤ 100 000 | 7
100 000 < input (t) ≤ 120 000 | 8
120 000 < input (t) ≤ 140 000 | 9
140 000 < input (t) ≤ 160 000 | 10
160 000 < input (t) ≤ 180 000 | 11
Input (t) > 180 000 | 12
Type 2: Product manufacture plants using materials from Type 1 plants | 5.1—Limits for heavy metals5.5—Limits forE. coliandSalmonellaspp.6—Stability7—Physical contaminants8—Organic matter and dry matter9—Viable seeds and plant propagules10—Plant response11—Growing media features | 5.1 | — | Limits for heavy metals | 5.5 | — | Limits forE. coliandSalmonellaspp. | 6 | — | Stability | 7 | — | Physical contaminants | 8 | — | Organic matter and dry matter | 9 | — | Viable seeds and plant propagules | 10 | — | Plant response | 11 | — | Growing media features | Output (m3) ≤ 5 000 | Representative combined samples from 2 batches according EN 12579(1)
5.1 | — | Limits for heavy metals
5.5 | — | Limits forE. coliandSalmonellaspp.
6 | — | Stability
7 | — | Physical contaminants
8 | — | Organic matter and dry matter
9 | — | Viable seeds and plant propagules
10 | — | Plant response
11 | — | Growing media features
Output (m3) > 5 000 | Representative combined samples from 4 batches according EN 12579
5.2—PAH | 5.2 | — | PAH | Output (m3) ≤ 5 000 | Representative combined sample(s) from 1 batch according EN 12579
5.2 | — | PAH
Output (m3) > 5 000 | Representative combined samples from 2 batches according EN 12579
Type 3: Product manufacture plants NOT using materials derived from waste or from animal by-products | 5.1—Limits for heavy metals5.5—Limits forE. coliandSalmonellaspp.6—Stability7—Physical contaminants8—Organic matter and dry matter9—Viable seeds and plant propagules10—Plant response11—Growing media features | 5.1 | — | Limits for heavy metals | 5.5 | — | Limits forE. coliandSalmonellaspp. | 6 | — | Stability | 7 | — | Physical contaminants | 8 | — | Organic matter and dry matter | 9 | — | Viable seeds and plant propagules | 10 | — | Plant response | 11 | — | Growing media features | Output (m3) ≤ 5 000 | Representative combined sample(s) from 1 batch according EN 12579
5.1 | — | Limits for heavy metals
5.5 | — | Limits forE. coliandSalmonellaspp.
6 | — | Stability
7 | — | Physical contaminants
8 | — | Organic matter and dry matter
9 | — | Viable seeds and plant propagules
10 | — | Plant response
11 | — | Growing media features
Output (m3) > 5 000 | Representative combined samples from 2 batches according EN 12579
5.2—PAH | 5.2 | — | PAH | Regardless the input/output | Representative combined sample(s) from 1 batch according EN 12579
5.2 | — | PAH
(1) EN 12579 Soil improvers and growing media. Sampling.

Sampling and test frequency for the following years

Appendix 2
Type of plant | Criteria | Annual input/output | Test frequency
Type 1: Treatment plants for waste or for animal by-products | 5.1—Limits for heavy metals5.5—Limits forE. coliandSalmonellaspp.6—Stability7—Physical contaminants8—Organic matter and dry matter9—Viable seeds and plant propagules10—Plant response11—Growing media features | 5.1 | — | Limits for heavy metals | 5.5 | — | Limits forE. coliandSalmonellaspp. | 6 | — | Stability | 7 | — | Physical contaminants | 8 | — | Organic matter and dry matter | 9 | — | Viable seeds and plant propagules | 10 | — | Plant response | 11 | — | Growing media features | Input (t) ≤ 1 000 | 1
5.1 | — | Limits for heavy metals
5.5 | — | Limits forE. coliandSalmonellaspp.
6 | — | Stability
7 | — | Physical contaminants
8 | — | Organic matter and dry matter
9 | — | Viable seeds and plant propagules
10 | — | Plant response
11 | — | Growing media features
Input (t) > 1 000 | number of analyses per year = amount of annual input material (in tonnes)/10 000 tonnes + 1Minimum 2 and maximum 12
5.2—PAH | 5.2 | — | PAH | Input (t) ≤ 10 000 | 0,25 (once per 4 years)
5.2 | — | PAH
10 000 < input (t) ≤ 25 000 | 0,5 (once per 2 years)
25 000 < input (t) ≤ 50 000 | 1
50 000 < input (t) ≤ 100 000 | 2
100 000 < input (t) ≤ 150 000 | 3
150 000 < input (t) ≤ 200 000 | 4
200 000 < input (t) ≤ 250 000 | 5
250 000 < input (t) ≤ 300 000 | 6
300 000 < input (t) ≤ 350 000 | 7
350 000 < input (t) ≤ 400 000 | 8
400 000 < input (t) ≤ 450 000 | 9
450 000 < input (t) ≤ 500 000 | 10
500 000 < input (t) ≤ 550 000 | 11
Input (t) > 550 000 | 12
Type 2: Product manufacture plants using materials from Type 1 plants | 5.1—Limits for heavy metals5.5—Limits forE. coliandSalmonellaspp.6—Stability7—Physical contaminants8—Organic matter and dry matter9—Viable seeds and plant propagules10—Plant response11—Growing media features | 5.1 | — | Limits for heavy metals | 5.5 | — | Limits forE. coliandSalmonellaspp. | 6 | — | Stability | 7 | — | Physical contaminants | 8 | — | Organic matter and dry matter | 9 | — | Viable seeds and plant propagules | 10 | — | Plant response | 11 | — | Growing media features | Output (m3) ≤ 5 000 | Representative combined sample(s) from 1 batch according EN 12579
5.1 | — | Limits for heavy metals
5.5 | — | Limits forE. coliandSalmonellaspp.
6 | — | Stability
7 | — | Physical contaminants
8 | — | Organic matter and dry matter
9 | — | Viable seeds and plant propagules
10 | — | Plant response
11 | — | Growing media features
Output (m3) > 5 000 | Representative combined samples from 2 batches according EN 12579
5.2—PAH | 5.2 | — | PAH | Output (m3) ≤ 15 000 | Representative combined sample(s) from 1 batch according EN 12579, once each 4 years
5.2 | — | PAH
15 000 < Output (m3) ≤ 40 000 | Representative combined sample(s) from 1 batch according EN 12579, each 2 years
Output (m3) > 40 000 | Representative combined sample(s) from 1 batch according EN 12579, each year
Type 3: Product manufacture plants NOT using materials derived from waste or from animal by-products | 5.1—Limits for heavy metals5.5—Limits forE. coliandSalmonellaspp.6—Stability7—Physical contaminants8—Organic matter and dry matter9—Viable weed seeds and plant propagules10—Plant response11—Growing media features | 5.1 | — | Limits for heavy metals | 5.5 | — | Limits forE. coliandSalmonellaspp. | 6 | — | Stability | 7 | — | Physical contaminants | 8 | — | Organic matter and dry matter | 9 | — | Viable weed seeds and plant propagules | 10 | — | Plant response | 11 | — | Growing media features | Regardless the input/output | Representative combined sample(s) from 1 batch according EN 12579
5.1 | — | Limits for heavy metals
5.5 | — | Limits forE. coliandSalmonellaspp.
6 | — | Stability
7 | — | Physical contaminants
8 | — | Organic matter and dry matter
9 | — | Viable weed seeds and plant propagules
10 | — | Plant response
11 | — | Growing media features
5.2—PAH | 5.2 | — | PAH | Regardless the input/output | Representative combined sample(s) from 1 batch according EN 12579, once each 4 years
5.2 | — | PAH

Pending: 32015D0778

19.5.2015 EN Official Journal of the European Union L 122/31
(1) On 20 April 2015, the Council confirmed a strong commitment to act in order to prevent human tragedies resulting from the smuggling of people across the Mediterranean.
(2) On 23 April 2015, the European Council expressed its indignation about the situation in the Mediterranean and underlined that the Union will mobilise all efforts at its disposal to prevent further loss of life at sea and to tackle the root causes of this human emergency, in cooperation with the countries of origin and transit, and that the immediate priority is to prevent more people from dying at sea. The European Council committed to strengthening the Union's presence at sea, to preventing illegal migration flows and to reinforcing internal solidarity and responsibility.
(3) The European Council of 23 April 2015 also committed to fighting the traffickers in accordance with international law, by undertaking systematic efforts to identify, capture and destroy vessels before they are used by traffickers, and invited the High Representative of the Union for Foreign Affairs and Security Policy (HR) to start preparations for a possible Common Security and Defence Policy (CSDP) operation to this effect.
(4) On 11 May 2015, the HR informed the UN Security Council about the crisis of migrants in the Mediterranean and the ongoing preparation for a possible Union naval operation, in the framework of the Union's Common Security and Defence Policy. In this regard, she expressed the need for the Union to work with the support of the UN Security Council.
(5) On 18 May 2015, the Council approved the crisis management concept for a CSDP operation to disrupt the business model of smugglers in the Southern Central Mediterranean.
(6) The Union CSDP operation will be conducted in accordance with international law, in particular with the relevant provisions of the 1982 United Nations Convention on the Law of the Sea (UNCLOS), the 2000 Protocols against the Smuggling of Migrants by Land, Sea and Air (the Protocol against the Smuggling of Migrants) and to Prevent, Suppress and Punish Trafficking in Persons, especially Women and Children, supplementing the United Nations Convention against Transnational Organized Crime, the 1974 International Convention for the Safety of Life at Sea (SOLAS), the 1979 International Convention on Maritime Search and Rescue (SAR), the 1976 Convention for the Protection of the Marine Environment and the Coastal Region of the Mediterranean (Barcelona Convention), the 1951 Geneva Convention relating to the Status of Refugees and the principle of non-refoulement and international human rights law.The UNCLOS, SOLAS and SAR Conventions include the obligation to assist persons in distress at sea and to deliver survivors to a place of safety, and to that end the vessels assigned to EUNAVFOR MED will be ready and equipped to perform the related duties under the coordination of the competent Rescue Coordination Centre.
(7) On the high seas, in accordance with relevant domestic and international law, States may interdict vessels suspected of smuggling migrants, where there is flag State authorisation to board and search the vessel or where the vessel is without nationality, and may take appropriate measures against the vessels, persons and cargo.
(8) Measures may also be taken in the territorial or internal waters, territory or airspace of a State against vessels suspected of involvement in human smuggling or trafficking, with the consent of that State or pursuant to a UN Security Council Resolution, or both.
(9) A State may take appropriate measures against persons present on its territory whom it suspects of smuggling or trafficking humans with a view to their possible arrest and prosecution, in accordance with international law and its domestic law.
(10) The Political and Security Committee (PSC) should exercise, under the responsibility of the Council and of the HR, political control over the Union crisis management operation, provide it with strategic direction and take the relevant decisions in accordance with the third paragraph of Article 38 of the Treaty on European Union (TEU).
(11) Pursuant to Article 41(2) TEU, and in accordance with Council Decision (CFSP) 2015/528(1), the operational expenditure arising from this Decision, which has military or defence implications, is to be borne by the Member States.
(12) In accordance with Article 5 of Protocol No 22 on the position of Denmark annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark does not participate in the elaboration and implementation of decisions and actions of the Union which have defence implications. Consequently, Denmark is not participating in the adoption of this Decision, is neither bound by it nor subject to its application, and does not participate in the financing of this operation,
(a) in a first phase, support the detection and monitoring of migration networks through information gathering and patrolling on the high seas in accordance with international law;
(b) in a second phase,(i)conduct boarding, search, seizure and diversion on the high seas of vessels suspected of being used for human smuggling or trafficking, under the conditions provided for by applicable international law, including UNCLOS and the Protocol against the Smuggling of Migrants;(ii)in accordance with any applicable UN Security Council Resolution or consent by the coastal State concerned, conduct boarding, search, seizure and diversion, on the high seas or in the territorial and internal waters of that State, of vessels suspected of being used for human smuggling or trafficking, under the conditions set out in that Resolution or consent; (i) conduct boarding, search, seizure and diversion on the high seas of vessels suspected of being used for human smuggling or trafficking, under the conditions provided for by applicable international law, including UNCLOS and the Protocol against the Smuggling of Migrants; (ii) in accordance with any applicable UN Security Council Resolution or consent by the coastal State concerned, conduct boarding, search, seizure and diversion, on the high seas or in the territorial and internal waters of that State, of vessels suspected of being used for human smuggling or trafficking, under the conditions set out in that Resolution or consent;
(i) conduct boarding, search, seizure and diversion on the high seas of vessels suspected of being used for human smuggling or trafficking, under the conditions provided for by applicable international law, including UNCLOS and the Protocol against the Smuggling of Migrants;
(ii) in accordance with any applicable UN Security Council Resolution or consent by the coastal State concerned, conduct boarding, search, seizure and diversion, on the high seas or in the territorial and internal waters of that State, of vessels suspected of being used for human smuggling or trafficking, under the conditions set out in that Resolution or consent;
(i) conduct boarding, search, seizure and diversion on the high seas of vessels suspected of being used for human smuggling or trafficking, under the conditions provided for by applicable international law, including UNCLOS and the Protocol against the Smuggling of Migrants;
(ii) in accordance with any applicable UN Security Council Resolution or consent by the coastal State concerned, conduct boarding, search, seizure and diversion, on the high seas or in the territorial and internal waters of that State, of vessels suspected of being used for human smuggling or trafficking, under the conditions set out in that Resolution or consent;
(c) in a third phase, in accordance with any applicable UN Security Council Resolution or consent by the coastal State concerned, take all necessary measures against a vessel and related assets, including through disposing of them or rendering them inoperable, which are suspected of being used for human smuggling or trafficking, in the territory of that State, under the conditions set out in that Resolution or consent.
(a) up to the level provided in the applicable Security of Information Agreements concluded between the Union and the third State concerned; or
(b) up to the ‘CONFIDENTIEL UE/EU CONFIDENTIAL’ level in other cases.
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union, and in particular Articles 42(4) and 43(2) thereof,
Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
(1) On 20 April 2015, the Council confirmed a strong commitment to act in order to prevent human tragedies resulting from the smuggling of people across the Mediterranean.
(2) On 23 April 2015, the European Council expressed its indignation about the situation in the Mediterranean and underlined that the Union will mobilise all efforts at its disposal to prevent further loss of life at sea and to tackle the root causes of this human emergency, in cooperation with the countries of origin and transit, and that the immediate priority is to prevent more people from dying at sea. The European Council committed to strengthening the Union’s presence at sea, to preventing illegal migration flows and to reinforcing internal solidarity and responsibility.
(3) The European Council of 23 April 2015 also committed to fighting the traffickers in accordance with international law, by undertaking systematic efforts to identify, capture and destroy vessels before they are used by traffickers, and invited the High Representative of the Union for Foreign Affairs and Security Policy (HR) to start preparations for a possible Common Security and Defence Policy (CSDP) operation to this effect.
(4) On 11 May 2015, the HR informed the UN Security Council about the crisis of migrants in the Mediterranean and the ongoing preparation for a possible Union naval operation, in the framework of the Union’s Common Security and Defence Policy. In this regard, she expressed the need for the Union to work with the support of the UN Security Council.
(5) On 18 May 2015, the Council approved the crisis management concept for a CSDP operation to disrupt the business model of smugglers in the Southern Central Mediterranean.
(6) The Union CSDP operation will be conducted in accordance with international law, in particular with the relevant provisions of the 1982 United Nations Convention on the Law of the Sea (UNCLOS), the 2000 Protocols against the Smuggling of Migrants by Land, Sea and Air (the Protocol against the Smuggling of Migrants) and to Prevent, Suppress and Punish Trafficking in Persons, especially Women and Children, supplementing the United Nations Convention against Transnational Organized Crime, the 1974 International Convention for the Safety of Life at Sea (SOLAS), the 1979 International Convention on Maritime Search and Rescue (SAR), the 1976 Convention for the Protection of the Marine Environment and the Coastal Region of the Mediterranean (Barcelona Convention), the 1951 Geneva Convention relating to the Status of Refugees and the principle of non-refoulement and international human rights law.The UNCLOS, SOLAS and SAR Conventions include the obligation to assist persons in distress at sea and to deliver survivors to a place of safety, and to that end the vessels assigned to EUNAVFOR MED will be ready and equipped to perform the related duties under the coordination of the competent Rescue Coordination Centre.
(7) On the high seas, in accordance with relevant domestic and international law, States may interdict vessels suspected of smuggling migrants, where there is flag State authorisation to board and search the vessel or where the vessel is without nationality, and may take appropriate measures against the vessels, persons and cargo.
(8) Measures may also be taken in the territorial or internal waters, territory or airspace of a State against vessels suspected of involvement in human smuggling or trafficking, with the consent of that State or pursuant to a UN Security Council Resolution, or both.
(9) A State may take appropriate measures against persons present on its territory whom it suspects of smuggling or trafficking humans with a view to their possible arrest and prosecution, in accordance with international law and its domestic law.
(10) The Political and Security Committee (PSC) should exercise, under the responsibility of the Council and of the HR, political control over the Union crisis management operation, provide it with strategic direction and take the relevant decisions in accordance with the third paragraph of Article 38 of the Treaty on European Union (TEU).
(11) Pursuant to Article 41(2) TEU, and in accordance with Council Decision (CFSP) 2015/528(1), the operational expenditure arising from this Decision, which has military or defence implications, is to be borne by the Member States.
(12) In accordance with Article 5 of Protocol No 22 on the position of Denmark annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark does not participate in the elaboration and implementation of decisions and actions of the Union which have defence implications. Consequently, Denmark is not participating in the adoption of this Decision, is neither bound by it nor subject to its application, and does not participate in the financing of this operation,
HAS ADOPTED THIS DECISION:

Mission
Article 1
1. The Union shall conduct a military crisis management operation contributing to the disruption of the business model of human smuggling and trafficking networks in the Southern Central Mediterranean (EUNAVFOR MED), achieved by undertaking systematic efforts to identify, capture and dispose of vessels and assets used or suspected of being used by smugglers or traffickers, in accordance with applicable international law, including UNCLOS and any UN Security Council Resolution.
2. The area of operation shall be defined, before the launching of EUNAVFOR MED, in the relevant planning documents to be approved by the Council.

Mandate
Article 2
1. EUNAVFOR MED shall operate in accordance with the political, strategic and politico-military objectives set out in the Crisis Management Concept approved by the Council on 18 May 2015.
2. EUNAVFOR MED shall be conducted in sequential phases, and in accordance with the requirements of international law. EUNAVFOR MED shall:
(a)
in a first phase, support the detection and monitoring of migration networks through information gathering and patrolling on the high seas in accordance with international law;
(b)
in a second phase,
(i)
conduct boarding, search, seizure and diversion on the high seas of vessels suspected of being used for human smuggling or trafficking, under the conditions provided for by applicable international law, including UNCLOS and the Protocol against the Smuggling of Migrants;
(ii)
in accordance with any applicable UN Security Council Resolution or consent by the coastal State concerned, conduct boarding, search, seizure and diversion, on the high seas or in the territorial and internal waters of that State, of vessels suspected of being used for human smuggling or trafficking, under the conditions set out in that Resolution or consent;
(c)
in a third phase, in accordance with any applicable UN Security Council Resolution or consent by the coastal State concerned, take all necessary measures against a vessel and related assets, including through disposing of them or rendering them inoperable, which are suspected of being used for human smuggling or trafficking, in the territory of that State, under the conditions set out in that Resolution or consent.
3. The Council shall assess whether the conditions for transition beyond the first phase have been met, taking into account any applicable UN Security Council Resolution and consent by the coastal States concerned.
4. EUNAVFOR MED may collect, in accordance with applicable law, personal data concerning persons taken on board ships participating in EUNAVFOR MED related to characteristics likely to assist in their identification, including fingerprints, as well as the following particulars, with the exclusion of other personal data: surname, maiden name, given names and any alias or assumed name; date and place of birth, nationality, sex; place of residence, profession and whereabouts; driving licenses, identification documents and passport data. It may transmit such data and data related to the vessels and equipment used by such persons to the relevant law enforcement authorities of Member States and/or to competent Union bodies.

Appointment of the EU Operation Commander
Article 3
Rear Admiral Enrico Credendino is hereby appointed EU Operation Commander of EUNAVFOR MED.

Designation of the EU Operation Headquarters
Article 4
The Operation Headquarters of EUNAVFOR MED shall be located in Rome, Italy.

Planning and launch of the operation
Article 5
The Decision to launch EUNAVFOR MED shall be adopted by the Council, upon the recommendation of the Operation Commander of EUNAVFOR MED following approval of the Operation Plan and of the Rules of Engagement necessary for the execution of the mandate.

Political control and strategic direction
Article 6
1. Under the responsibility of the Council and of the HR, the PSC shall exercise the political control and strategic direction of EUNAVFOR MED. The Council hereby authorises the PSC to take the relevant decisions in accordance with Article 38 TEU. This authorisation shall include the powers to amend the planning documents, including the Operations Plan, the Chain of Command and the Rules of Engagement. It shall also include the powers to take decisions on the appointment of the EU Operation Commander and the EU Force Commander. The powers of decision with respect to the objectives and termination of the EU military operation shall remain vested in the Council. Subject to Article 2(3) of this Decision, the PSC shall have the power to decide when to make the transition between the different phases of the operation.
2. The PSC shall report to the Council at regular intervals.
3. The Chairman of the EU Military Committee (EUMC) shall, at regular intervals, report to the PSC on the conduct of EUNAVFOR MED. The PSC may invite the EU Operation Commander or the EU Force Commander to its meetings, as appropriate.

Military direction
Article 7
1. The EUMC shall monitor the proper execution of EUNAVFOR MED conducted under the responsibility of the EU Operation Commander.
2. The EU Operation Commander shall, at regular intervals, report to the EUMC. The EUMC may invite the EU Operation Commander or the EU Force Commander to its meetings, as appropriate.
3. The Chairman of the EUMC shall act as the primary point of contact with the EU Operation Commander.

Consistency of the Union’s response and coordination
Article 8
1. The HR shall ensure the implementation of this Decision and its consistency with the Union’s external action as a whole, including the Union’s development programmes and its humanitarian assistance.
2. The HR, assisted by the European External Action Service (EEAS), shall act as the primary point of contact with the United Nations, the authorities of the countries in the region, and other international and bilateral actors, including NATO, the African Union and the League of Arab States.
3. EUNAVFOR MED shall cooperate with the relevant Member State authorities and shall establish a coordination mechanism, and as appropriate, conclude arrangements with other Union agencies and bodies, in particular FRONTEX, EUROPOL, EUROJUST, European Asylum Support Office and relevant CSDP missions.

Participation by third States
Article 9
1. Without prejudice to the Union’s decision-making autonomy or to the single institutional framework, and in accordance with the relevant guidelines of the European Council, third States may be invited to participate in the operation.
2. The Council hereby authorises the PSC to invite third States to offer contributions and to take the relevant decisions on acceptance of the proposed contributions, upon the recommendation of the EU Operations Commander and the EUMC.
3. Detailed arrangements for the participation by third States shall be the subject of agreements concluded pursuant to Article 37 TEU and in accordance with the procedure laid down in Article 218 of the Treaty on the Functioning of the European Union (TFEU). Where the Union and a third State have concluded an agreement establishing a framework for the latter’s participation in crisis management missions of the Union, the provisions of such an agreement shall apply in the context of EUNAVFOR MED.
4. Third States making significant military contributions to EUNAVFOR MED shall have the same rights and obligations in terms of day-to-day management of the operation as Member States taking part in the operation.
5. The Council hereby authorises the PSC to take relevant decisions on the setting-up of a Committee of Contributors, should third States provide significant military contributions.

Status of Union-led personnel
Article 10
The status of Union-led units and personnel shall be defined where necessary in accordance with international law.

Financial arrangements
Article 11
1. The common costs of the EU military operation shall be administered in accordance with Decision (CFSP) 2015/528.
2. The financial reference amount for the common costs of EUNAVFOR MED shall be EUR 11,82 million. The percentage of the reference amount referred to in Article 25(1) of Decision (CFSP) 2015/528 shall be 70 % in commitments and 40 % for payments.

Release of information
Article 12
1. The HR shall be authorised to release to the third States associated with this Decision, as appropriate and in accordance with the needs of EUNAVFOR MED, EU classified information generated for the purposes of the operation, in accordance with Council Decision 2013/488/EU(2), as follows:
(a)
up to the level provided in the applicable Security of Information Agreements concluded between the Union and the third State concerned; or
(b)
up to the ‘CONFIDENTIEL UE/EU CONFIDENTIAL’ level in other cases.
2. The HR shall also be authorised to release to the UN, in accordance with the operational needs of EUNAVFOR MED, EU classified information up to ‘RESTREINT UE/EU RESTRICTED’ level which are generated for the purposes of EUNAVFOR MED, in accordance with Decision 2013/488/EU. Arrangements between the HR and the competent authorities of the United Nations shall be drawn up for this purpose.
3. The HR shall be authorised to release to the third States associated with this Decision any EU non-classified documents connected with the deliberations of the Council relating to the operation and covered by the obligation of professional secrecy pursuant to Article 6(1) of the Council’s Rules of Procedure(3).
4. The HR may delegate such authorisations, as well as the ability to conclude the arrangements referred to in this Article, to EEAS officials, to the EU Operation Commander or to the EU Force Commander in accordance with section VII of Annex VI to Decision 2013/488/EU.

Entry into force and termination
Article 13
This Decision shall enter into force on the date of its adoption.
EUNAVFOR MED shall end no later than 12 months after having reached Full Operational Capability (FOC).
This Decision shall be repealed as from the date of closure of the EU Operation Headquarters in accordance with the plans approved for the termination of EUNAVFOR MED, and without prejudice to the procedures regarding the audit and presentation of the accounts of EUNAVFOR MED laid down in Decision (CFSP) 2015/528.

THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union, and in particular Articles 42(4) and 43(2) thereof,
Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
(1) On 20 April 2015, the Council confirmed a strong commitment to act in order to prevent human tragedies resulting from the smuggling of people across the Mediterranean.
(2) On 23 April 2015, the European Council expressed its indignation about the situation in the Mediterranean and underlined that the Union will mobilise all efforts at its disposal to prevent further loss of life at sea and to tackle the root causes of this human emergency, in cooperation with the countries of origin and transit, and that the immediate priority is to prevent more people from dying at sea. The European Council committed to strengthening the Union’s presence at sea, to preventing illegal migration flows and to reinforcing internal solidarity and responsibility.
(3) The European Council of 23 April 2015 also committed to fighting the traffickers in accordance with international law, by undertaking systematic efforts to identify, capture and destroy vessels before they are used by traffickers, and invited the High Representative of the Union for Foreign Affairs and Security Policy (HR) to start preparations for a possible Common Security and Defence Policy (CSDP) operation to this effect.
(4) On 11 May 2015, the HR informed the UN Security Council about the crisis of migrants in the Mediterranean and the ongoing preparation for a possible Union naval operation, in the framework of the Union’s Common Security and Defence Policy. In this regard, she expressed the need for the Union to work with the support of the UN Security Council.
(5) On 18 May 2015, the Council approved the crisis management concept for a CSDP operation to disrupt the business model of smugglers in the Southern Central Mediterranean.
(6) The Union CSDP operation will be conducted in accordance with international law, in particular with the relevant provisions of the 1982 United Nations Convention on the Law of the Sea (UNCLOS), the 2000 Protocols against the Smuggling of Migrants by Land, Sea and Air (the Protocol against the Smuggling of Migrants) and to Prevent, Suppress and Punish Trafficking in Persons, especially Women and Children, supplementing the United Nations Convention against Transnational Organized Crime, the 1974 International Convention for the Safety of Life at Sea (SOLAS), the 1979 International Convention on Maritime Search and Rescue (SAR), the 1976 Convention for the Protection of the Marine Environment and the Coastal Region of the Mediterranean (Barcelona Convention), the 1951 Geneva Convention relating to the Status of Refugees and the principle of non-refoulement and international human rights law.The UNCLOS, SOLAS and SAR Conventions include the obligation to assist persons in distress at sea and to deliver survivors to a place of safety, and to that end the vessels assigned to EUNAVFOR MED will be ready and equipped to perform the related duties under the coordination of the competent Rescue Coordination Centre.
(7) On the high seas, in accordance with relevant domestic and international law, States may interdict vessels suspected of smuggling migrants, where there is flag State authorisation to board and search the vessel or where the vessel is without nationality, and may take appropriate measures against the vessels, persons and cargo.
(8) Measures may also be taken in the territorial or internal waters, territory or airspace of a State against vessels suspected of involvement in human smuggling or trafficking, with the consent of that State or pursuant to a UN Security Council Resolution, or both.
(9) A State may take appropriate measures against persons present on its territory whom it suspects of smuggling or trafficking humans with a view to their possible arrest and prosecution, in accordance with international law and its domestic law.
(10) The Political and Security Committee (PSC) should exercise, under the responsibility of the Council and of the HR, political control over the Union crisis management operation, provide it with strategic direction and take the relevant decisions in accordance with the third paragraph of Article 38 of the Treaty on European Union (TEU).
(11) Pursuant to Article 41(2) TEU, and in accordance with Council Decision (CFSP) 2015/528(1), the operational expenditure arising from this Decision, which has military or defence implications, is to be borne by the Member States.
(12) In accordance with Article 5 of Protocol No 22 on the position of Denmark annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark does not participate in the elaboration and implementation of decisions and actions of the Union which have defence implications. Consequently, Denmark is not participating in the adoption of this Decision, is neither bound by it nor subject to its application, and does not participate in the financing of this operation,
HAS ADOPTED THIS DECISION:

Mission

1. The Union shall conduct a military crisis management operation contributing to the disruption of the business model of human smuggling and trafficking networks in the Southern Central Mediterranean (EUNAVFOR MED), achieved by undertaking systematic efforts to identify, capture and dispose of vessels and assets used or suspected of being used by smugglers or traffickers, in accordance with applicable international law, including UNCLOS and any UN Security Council Resolution.
2. The area of operation shall be defined, before the launching of EUNAVFOR MED, in the relevant planning documents to be approved by the Council.

Mandate

1. EUNAVFOR MED shall operate in accordance with the political, strategic and politico-military objectives set out in the Crisis Management Concept approved by the Council on 18 May 2015.
2. EUNAVFOR MED shall be conducted in sequential phases, and in accordance with the requirements of international law. EUNAVFOR MED shall:
(a)
in a first phase, support the detection and monitoring of migration networks through information gathering and patrolling on the high seas in accordance with international law;
(b)
in a second phase,
(i)
conduct boarding, search, seizure and diversion on the high seas of vessels suspected of being used for human smuggling or trafficking, under the conditions provided for by applicable international law, including UNCLOS and the Protocol against the Smuggling of Migrants;
(ii)
in accordance with any applicable UN Security Council Resolution or consent by the coastal State concerned, conduct boarding, search, seizure and diversion, on the high seas or in the territorial and internal waters of that State, of vessels suspected of being used for human smuggling or trafficking, under the conditions set out in that Resolution or consent;
(c)
in a third phase, in accordance with any applicable UN Security Council Resolution or consent by the coastal State concerned, take all necessary measures against a vessel and related assets, including through disposing of them or rendering them inoperable, which are suspected of being used for human smuggling or trafficking, in the territory of that State, under the conditions set out in that Resolution or consent.
3. The Council shall assess whether the conditions for transition beyond the first phase have been met, taking into account any applicable UN Security Council Resolution and consent by the coastal States concerned.
4. EUNAVFOR MED may collect, in accordance with applicable law, personal data concerning persons taken on board ships participating in EUNAVFOR MED related to characteristics likely to assist in their identification, including fingerprints, as well as the following particulars, with the exclusion of other personal data: surname, maiden name, given names and any alias or assumed name; date and place of birth, nationality, sex; place of residence, profession and whereabouts; driving licenses, identification documents and passport data. It may transmit such data and data related to the vessels and equipment used by such persons to the relevant law enforcement authorities of Member States and/or to competent Union bodies.

Appointment of the EU Operation Commander

Rear Admiral Enrico Credendino is hereby appointed EU Operation Commander of EUNAVFOR MED.

Designation of the EU Operation Headquarters

The Operation Headquarters of EUNAVFOR MED shall be located in Rome, Italy.

Planning and launch of the operation

The Decision to launch EUNAVFOR MED shall be adopted by the Council, upon the recommendation of the Operation Commander of EUNAVFOR MED following approval of the Operation Plan and of the Rules of Engagement necessary for the execution of the mandate.

Political control and strategic direction

1. Under the responsibility of the Council and of the HR, the PSC shall exercise the political control and strategic direction of EUNAVFOR MED. The Council hereby authorises the PSC to take the relevant decisions in accordance with Article 38 TEU. This authorisation shall include the powers to amend the planning documents, including the Operations Plan, the Chain of Command and the Rules of Engagement. It shall also include the powers to take decisions on the appointment of the EU Operation Commander and the EU Force Commander. The powers of decision with respect to the objectives and termination of the EU military operation shall remain vested in the Council. Subject to Article 2(3) of this Decision, the PSC shall have the power to decide when to make the transition between the different phases of the operation.
2. The PSC shall report to the Council at regular intervals.
3. The Chairman of the EU Military Committee (EUMC) shall, at regular intervals, report to the PSC on the conduct of EUNAVFOR MED. The PSC may invite the EU Operation Commander or the EU Force Commander to its meetings, as appropriate.

Military direction

1. The EUMC shall monitor the proper execution of EUNAVFOR MED conducted under the responsibility of the EU Operation Commander.
2. The EU Operation Commander shall, at regular intervals, report to the EUMC. The EUMC may invite the EU Operation Commander or the EU Force Commander to its meetings, as appropriate.
3. The Chairman of the EUMC shall act as the primary point of contact with the EU Operation Commander.

Consistency of the Union's response and coordination

1. The HR shall ensure the implementation of this Decision and its consistency with the Union’s external action as a whole, including the Union’s development programmes and its humanitarian assistance.
2. The HR, assisted by the European External Action Service (EEAS), shall act as the primary point of contact with the United Nations, the authorities of the countries in the region, and other international and bilateral actors, including NATO, the African Union and the League of Arab States.
3. EUNAVFOR MED shall cooperate with the relevant Member State authorities and shall establish a coordination mechanism, and as appropriate, conclude arrangements with other Union agencies and bodies, in particular FRONTEX, EUROPOL, EUROJUST, European Asylum Support Office and relevant CSDP missions.

Participation by third States

1. Without prejudice to the Union’s decision-making autonomy or to the single institutional framework, and in accordance with the relevant guidelines of the European Council, third States may be invited to participate in the operation.
2. The Council hereby authorises the PSC to invite third States to offer contributions and to take the relevant decisions on acceptance of the proposed contributions, upon the recommendation of the EU Operations Commander and the EUMC.
3. Detailed arrangements for the participation by third States shall be the subject of agreements concluded pursuant to Article 37 TEU and in accordance with the procedure laid down in Article 218 of the Treaty on the Functioning of the European Union (TFEU). Where the Union and a third State have concluded an agreement establishing a framework for the latter’s participation in crisis management missions of the Union, the provisions of such an agreement shall apply in the context of EUNAVFOR MED.
4. Third States making significant military contributions to EUNAVFOR MED shall have the same rights and obligations in terms of day-to-day management of the operation as Member States taking part in the operation.
5. The Council hereby authorises the PSC to take relevant decisions on the setting-up of a Committee of Contributors, should third States provide significant military contributions.

Status of Union-led personnel

The status of Union-led units and personnel shall be defined where necessary in accordance with international law.

Financial arrangements

1. The common costs of the EU military operation shall be administered in accordance with Decision (CFSP) 2015/528.
2. The financial reference amount for the common costs of EUNAVFOR MED shall be EUR 11,82 million. The percentage of the reference amount referred to in Article 25(1) of Decision (CFSP) 2015/528 shall be 70 % in commitments and 40 % for payments.

Release of information

1. The HR shall be authorised to release to the third States associated with this Decision, as appropriate and in accordance with the needs of EUNAVFOR MED, EU classified information generated for the purposes of the operation, in accordance with Council Decision 2013/488/EU(2), as follows:
(a)
up to the level provided in the applicable Security of Information Agreements concluded between the Union and the third State concerned; or
(b)
up to the ‘CONFIDENTIEL UE/EU CONFIDENTIAL’ level in other cases.
2. The HR shall also be authorised to release to the UN, in accordance with the operational needs of EUNAVFOR MED, EU classified information up to ‘RESTREINT UE/EU RESTRICTED’ level which are generated for the purposes of EUNAVFOR MED, in accordance with Decision 2013/488/EU. Arrangements between the HR and the competent authorities of the United Nations shall be drawn up for this purpose.
3. The HR shall be authorised to release to the third States associated with this Decision any EU non-classified documents connected with the deliberations of the Council relating to the operation and covered by the obligation of professional secrecy pursuant to Article 6(1) of the Council’s Rules of Procedure(3).
4. The HR may delegate such authorisations, as well as the ability to conclude the arrangements referred to in this Article, to EEAS officials, to the EU Operation Commander or to the EU Force Commander in accordance with section VII of Annex VI to Decision 2013/488/EU.

Entry into force and termination

This Decision shall enter into force on the date of its adoption.
EUNAVFOR MED shall end no later than 12 months after having reached Full Operational Capability (FOC).
This Decision shall be repealed as from the date of closure of the EU Operation Headquarters in accordance with the plans approved for the termination of EUNAVFOR MED, and without prejudice to the procedures regarding the audit and presentation of the accounts of EUNAVFOR MED laid down in Decision (CFSP) 2015/528.

Pending: 32015D0701

30.4.2015 EN Official Journal of the European Union L 112/86
(1) On 17 and 18 April 2007, Monsanto Europe SA submitted to the Commission applications, in accordance with Article 8(4) and Article 20(4) of Regulation (EC) No 1829/2003, for renewal of the authorisations of existing food and feed produced from GT73 oilseed rape. The scope of the two renewal applications covers the continued marketing of existing food produced from oilseed rape GT73 (refined oil and food additives) and existing feed produced from oilseed rape GT73 (feed materials and feed additives) which were lawfully placed on the market in the Community before the date of entry into force of Regulation (EC) No 1829/2003. After the date of the entry into force of Regulation (EC) No 1829/2003, these products were notified to the European Commission according to Articles 8(1)(a), 8(1)(b) and 20(1)(b) of that Regulation and included in the Community Register of genetically modified food and feed.
(2) On 15 December 2009, the European Food Safety Authority (‘EFSA’) gave a favourable opinion on the renewal application in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that it is unlikely that the continued marketing of the food and feed produced from oilseed rape GT73 as described in the application will have any adverse effects on human or animal health or the environment, in the context of their intended uses(2).
(3) On 26 August 2010, Monsanto Europe SA submitted to the competent authority of the Netherlands an application, in accordance with Article 5 of Regulation (EC) No 1829/2003, for the placing on the market of foods and food ingredients containing, consisting of, or produced from oilseed rape GT73 (including pollen of oilseed rape GT73 and the accidental unintentional presence of viable seeds), with the exception of processed oil and food additives. The application does not include cultivation in the EU.
(4) In accordance with Article 5(5) of Regulation (EC) No 1829/2003, that application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(3), and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(5) On 12 February 2013, EFSA gave a favourable opinion on the new application in accordance with Article 6 Regulation (EC) No 1829/2003. It concluded that there is no indication of safety concerns for the human health in the context of the uses covered by the application, and in particular in either oilseed rape GT73 pollen/pollen-containing dietary supplements or the adventitious presence of trace levels of seeds in human foods(4). However, due to the lack of availability of relevant consumption and safety data, EFSA could not perform an equivalent assessment with isolated seed protein. EFSA also concluded that the environmental risk assessment of GT73 did not identify any safety concerns, in the context of its intended uses.
(6) On 19 March 2013, the Commission asked EFSA to complete its assessment to cover all possible uses of oilseed rape GT73 requested in the application.
(7) Subsequently, on 8 May 2013, Monsanto Europe SA informed the Commission that it does not intend to market isolated protein products from GT73 in the EU. Taking into account the fact that this particular use is very limited and accidental presence of the isolated seed protein in the food chain is very unlikely, it could be excluded from the scope of this Decision.
(8) In both opinions, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultations of the national competent authorities as provided for in Article 6(4) of Regulation (EC) No 1829/2003.
(9) The environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(10) The use of feed containing or consisting of GT73 oilseed-rape and products other than food and feed containing it or consisting of it with the exception of cultivation, has already been authorised by Commission Decision 2005/635/EC(5).
(11) Taking into account those considerations, authorisation (renewal and new authorisation) should be granted to the foods and food ingredients containing, consisting of GT73 oilseed rape, with the exception of isolated seed protein, and to the food and feed produced from GT73 oilseed rape.
(12) A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(6).
(13) On the basis of the two EFSA opinions, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients containing or consisting of, and food and feed produced from oilseed rape GT73.
(14) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(7), lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 of that Regulation and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(15) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(8). The EFSA opinions do not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and in Article 18(5) of Regulation (EC) No 1829/2003.
(16) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(17) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and point (c) of Article 15(2) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(9).
(18) The applicant has been consulted on the measures provided for in this Decision.
(19) The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
(a) foods and food ingredients containing, consisting of, or produced from MON-ØØØ73-7 oilseed rape, with the exception of isolated seed protein;
(b) feed produced from MON-ØØØ73-7 oilseed rape.
Name : Monsanto Europe SA, Belgium
Address : Avenue de Tervueren 270-272, 1150 Brussels, Belgium
1. foods and food ingredients containing, consisting of, or produced from MON-ØØØ73-7 oilseed rape, with the exception of isolated seed protein;
2. feed produced from MON-ØØØ73-7 oilseed rape.
— Event-specific real-time PCR based method for the quantification of MON-ØØØ73-7 oilseed rape.
— Validated on genomic DNA, extracted from seeds by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
— Reference Material: AOCS 0304-A and AOCS 0304-B are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(1), and in particular Article 7(3), Article 11(3), Article 19(3) and Article 23(3) thereof,
(1) On 17 and 18 April 2007, Monsanto Europe SA submitted to the Commission applications, in accordance with Article 8(4) and Article 20(4) of Regulation (EC) No 1829/2003, for renewal of the authorisations of existing food and feed produced from GT73 oilseed rape. The scope of the two renewal applications covers the continued marketing of existing food produced from oilseed rape GT73 (refined oil and food additives) and existing feed produced from oilseed rape GT73 (feed materials and feed additives) which were lawfully placed on the market in the Community before the date of entry into force of Regulation (EC) No 1829/2003. After the date of the entry into force of Regulation (EC) No 1829/2003, these products were notified to the European Commission according to Articles 8(1)(a), 8(1)(b) and 20(1)(b) of that Regulation and included in the Community Register of genetically modified food and feed.
(2) On 15 December 2009, the European Food Safety Authority (‘EFSA’) gave a favourable opinion on the renewal application in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that it is unlikely that the continued marketing of the food and feed produced from oilseed rape GT73 as described in the application will have any adverse effects on human or animal health or the environment, in the context of their intended uses(2).
(3) On 26 August 2010, Monsanto Europe SA submitted to the competent authority of the Netherlands an application, in accordance with Article 5 of Regulation (EC) No 1829/2003, for the placing on the market of foods and food ingredients containing, consisting of, or produced from oilseed rape GT73 (including pollen of oilseed rape GT73 and the accidental unintentional presence of viable seeds), with the exception of processed oil and food additives. The application does not include cultivation in the EU.
(4) In accordance with Article 5(5) of Regulation (EC) No 1829/2003, that application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(3), and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(5) On 12 February 2013, EFSA gave a favourable opinion on the new application in accordance with Article 6 Regulation (EC) No 1829/2003. It concluded that there is no indication of safety concerns for the human health in the context of the uses covered by the application, and in particular in either oilseed rape GT73 pollen/pollen-containing dietary supplements or the adventitious presence of trace levels of seeds in human foods(4). However, due to the lack of availability of relevant consumption and safety data, EFSA could not perform an equivalent assessment with isolated seed protein. EFSA also concluded that the environmental risk assessment of GT73 did not identify any safety concerns, in the context of its intended uses.
(6) On 19 March 2013, the Commission asked EFSA to complete its assessment to cover all possible uses of oilseed rape GT73 requested in the application.
(7) Subsequently, on 8 May 2013, Monsanto Europe SA informed the Commission that it does not intend to market isolated protein products from GT73 in the EU. Taking into account the fact that this particular use is very limited and accidental presence of the isolated seed protein in the food chain is very unlikely, it could be excluded from the scope of this Decision.
(8) In both opinions, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultations of the national competent authorities as provided for in Article 6(4) of Regulation (EC) No 1829/2003.
(9) The environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(10) The use of feed containing or consisting of GT73 oilseed-rape and products other than food and feed containing it or consisting of it with the exception of cultivation, has already been authorised by Commission Decision 2005/635/EC(5).
(11) Taking into account those considerations, authorisation (renewal and new authorisation) should be granted to the foods and food ingredients containing, consisting of GT73 oilseed rape, with the exception of isolated seed protein, and to the food and feed produced from GT73 oilseed rape.
(12) A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(6).
(13) On the basis of the two EFSA opinions, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients containing or consisting of, and food and feed produced from oilseed rape GT73.
(14) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(7), lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 of that Regulation and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(15) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(8). The EFSA opinions do not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and in Article 18(5) of Regulation (EC) No 1829/2003.
(16) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(17) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and point (c) of Article 15(2) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(9).
(18) The applicant has been consulted on the measures provided for in this Decision.
(19) The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifiers
Article 1
Genetically modified oilseed rape (Brassica napusL.) GT73, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØØ73-7, as provided for in Regulation (EC) No 65/2004.

Authorisation
Article 2
The following products are authorised for the purposes of Article 4(2) and Article 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
(a)
foods and food ingredients containing, consisting of, or produced from MON-ØØØ73-7 oilseed rape, with the exception of isolated seed protein;
(b)
feed produced from MON-ØØØ73-7 oilseed rape.

Labelling
Article 3
For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘oilseed rape’.

Monitoring for environmental effects
Article 4
1. The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.
2. The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with Decision 2009/770/EC.

Community register
Article 5
The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder
Article 6
The authorisation holder shall be Monsanto Europe SA, Belgium, representing Monsanto Company, United States of America.

Validity
Article 7
This Decision shall apply for a period of 10 years from the date of its notification.

Addressee
Article 8
This Decision is addressed to Monsanto Europe SA, Belgium, Avenue de Tervueren 270-272, 1150 Brussels, Belgium, representing Monsanto Company, 800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States of America.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(1), and in particular Article 7(3), Article 11(3), Article 19(3) and Article 23(3) thereof,
(1) On 17 and 18 April 2007, Monsanto Europe SA submitted to the Commission applications, in accordance with Article 8(4) and Article 20(4) of Regulation (EC) No 1829/2003, for renewal of the authorisations of existing food and feed produced from GT73 oilseed rape. The scope of the two renewal applications covers the continued marketing of existing food produced from oilseed rape GT73 (refined oil and food additives) and existing feed produced from oilseed rape GT73 (feed materials and feed additives) which were lawfully placed on the market in the Community before the date of entry into force of Regulation (EC) No 1829/2003. After the date of the entry into force of Regulation (EC) No 1829/2003, these products were notified to the European Commission according to Articles 8(1)(a), 8(1)(b) and 20(1)(b) of that Regulation and included in the Community Register of genetically modified food and feed.
(2) On 15 December 2009, the European Food Safety Authority (‘EFSA’) gave a favourable opinion on the renewal application in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that it is unlikely that the continued marketing of the food and feed produced from oilseed rape GT73 as described in the application will have any adverse effects on human or animal health or the environment, in the context of their intended uses(2).
(3) On 26 August 2010, Monsanto Europe SA submitted to the competent authority of the Netherlands an application, in accordance with Article 5 of Regulation (EC) No 1829/2003, for the placing on the market of foods and food ingredients containing, consisting of, or produced from oilseed rape GT73 (including pollen of oilseed rape GT73 and the accidental unintentional presence of viable seeds), with the exception of processed oil and food additives. The application does not include cultivation in the EU.
(4) In accordance with Article 5(5) of Regulation (EC) No 1829/2003, that application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(3), and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(5) On 12 February 2013, EFSA gave a favourable opinion on the new application in accordance with Article 6 Regulation (EC) No 1829/2003. It concluded that there is no indication of safety concerns for the human health in the context of the uses covered by the application, and in particular in either oilseed rape GT73 pollen/pollen-containing dietary supplements or the adventitious presence of trace levels of seeds in human foods(4). However, due to the lack of availability of relevant consumption and safety data, EFSA could not perform an equivalent assessment with isolated seed protein. EFSA also concluded that the environmental risk assessment of GT73 did not identify any safety concerns, in the context of its intended uses.
(6) On 19 March 2013, the Commission asked EFSA to complete its assessment to cover all possible uses of oilseed rape GT73 requested in the application.
(7) Subsequently, on 8 May 2013, Monsanto Europe SA informed the Commission that it does not intend to market isolated protein products from GT73 in the EU. Taking into account the fact that this particular use is very limited and accidental presence of the isolated seed protein in the food chain is very unlikely, it could be excluded from the scope of this Decision.
(8) In both opinions, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultations of the national competent authorities as provided for in Article 6(4) of Regulation (EC) No 1829/2003.
(9) The environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(10) The use of feed containing or consisting of GT73 oilseed-rape and products other than food and feed containing it or consisting of it with the exception of cultivation, has already been authorised by Commission Decision 2005/635/EC(5).
(11) Taking into account those considerations, authorisation (renewal and new authorisation) should be granted to the foods and food ingredients containing, consisting of GT73 oilseed rape, with the exception of isolated seed protein, and to the food and feed produced from GT73 oilseed rape.
(12) A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(6).
(13) On the basis of the two EFSA opinions, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients containing or consisting of, and food and feed produced from oilseed rape GT73.
(14) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(7), lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 of that Regulation and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(15) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(8). The EFSA opinions do not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and in Article 18(5) of Regulation (EC) No 1829/2003.
(16) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(17) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and point (c) of Article 15(2) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(9).
(18) The applicant has been consulted on the measures provided for in this Decision.
(19) The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifiers

Genetically modified oilseed rape (Brassica napusL.) GT73, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØØ73-7, as provided for in Regulation (EC) No 65/2004.

Authorisation

The following products are authorised for the purposes of Article 4(2) and Article 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
(a)
foods and food ingredients containing, consisting of, or produced from MON-ØØØ73-7 oilseed rape, with the exception of isolated seed protein;
(b)
feed produced from MON-ØØØ73-7 oilseed rape.

Labelling

For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘oilseed rape’.

Monitoring for environmental effects

1. The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.
2. The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with Decision 2009/770/EC.

Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder

The authorisation holder shall be Monsanto Europe SA, Belgium, representing Monsanto Company, United States of America.

Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Addressee

This Decision is addressed to Monsanto Europe SA, Belgium, Avenue de Tervueren 270-272, 1150 Brussels, Belgium, representing Monsanto Company, 800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States of America.

(a)   Applicant and authorisation holder

ANNEX
Name | : | Monsanto Europe SA, Belgium
Address | : | Avenue de Tervueren 270-272, 1150 Brussels, Belgiumon behalf of Monsanto Company, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America.
(b) Designation and specification of the products

1. | foods and food ingredients containing, consisting of, or produced from MON-ØØØ73-7 oilseed rape, with the exception of isolated seed protein;
2. | feed produced from MON-ØØØ73-7 oilseed rape.The genetically modified MON-ØØØ73-7 oilseed rape, as described in the applications, expresses the CP4 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) and glyphosate oxidoreductase variant 247 (GOXv247) proteins which confer tolerance to glyphosate-based herbicides.
(c) Labelling
For the purposes of the specific labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘oilseed rape’.
(d) Method for detection

— | Event-specific real-time PCR based method for the quantification of MON-ØØØ73-7 oilseed rape.
— | Validated on genomic DNA, extracted from seeds by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
— | Reference Material: AOCS 0304-A and AOCS 0304-B are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm(e) Unique identifier
MON-ØØØ73-7
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity
Biosafety Clearing-House (to be entered in the Community register of genetically modified food and feed when notified).
(g) Conditions or restrictions on the placing on the market, use or handling of the products
Not required.
(h) Monitoring plan
Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC (to be entered in the Community register of genetically modified food and feed when notified).
(i) Post-market monitoring requirements for the use of the food for human consumption
Not required.

Pending: 32015D0700

30.4.2015 EN Official Journal of the European Union L 112/81
(1) On 2 February 2011, Monsanto Europe S.A. submitted to the competent authority of the Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from soybean MON87708 (‘the application’).
(2) The application also covers the placing on the market of soybean MON87708 in products consisting of it or containing it for any other uses than food and feed as any other soybean, with the exception of cultivation.
(3) In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 3 October 2013, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that soybean MON87708, as described in the application, is as safe as its non-genetically modified counterpart and reference varieties with respect to potential effects on human and animal health or the environment, in the context of its intended uses(3).
(5) In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of that Regulation.
(6) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(7) Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified soybean MON87708.
(8) A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(4).
(9) On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from soybean MON87708. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.
(10) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(5)lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(11) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(6). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.
(12) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(13) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(7).
(14) The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
(a) foods and food ingredients containing, consisting of, or produced from soybean MON-877Ø8-9;
(b) feed containing, consisting of, or produced from soybean MON-877Ø8-9;
(c) soybean MON-877Ø8-9 in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.
Name : Monsanto Europe S.A.
Address : Avenue de Tervuren 270-272, B-1150 Brussels — Belgium
(1) foods and food ingredients containing, consisting of, or produced from soybean MON-877Ø8-9;
(2) feed containing, consisting of, or produced from soybean MON-877Ø8-9;
(3) soybean MON-877Ø8-9 in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.
(1) for the purposes of the specific labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’;
(2) the words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of soybean MON-877Ø8-9 with the exception of products referred to in point (a) of Article 2.
— event-specific real-time PCR based method for the quantification of soybean MON-877Ø8-9,
— validated on genomic DNA, extracted from seeds, by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
— Reference Material: AOCS 0311-A and AOCS 0906-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(1), and in particular Articles 7(3) and 19(3) thereof,
(1) On 2 February 2011, Monsanto Europe S.A. submitted to the competent authority of the Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from soybean MON87708 (‘the application’).
(2) The application also covers the placing on the market of soybean MON87708 in products consisting of it or containing it for any other uses than food and feed as any other soybean, with the exception of cultivation.
(3) In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 3 October 2013, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that soybean MON87708, as described in the application, is as safe as its non-genetically modified counterpart and reference varieties with respect to potential effects on human and animal health or the environment, in the context of its intended uses(3).
(5) In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of that Regulation.
(6) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(7) Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified soybean MON87708.
(8) A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(4).
(9) On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from soybean MON87708. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.
(10) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(5)lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(11) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(6). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.
(12) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(13) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(7).
(14) The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier
Article 1
Genetically modified soybean (Glycine max(L.) Merr.) MON87708, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-877Ø8-9, as provided for in Regulation (EC) No 65/2004.

Authorisation
Article 2
The following products are authorised for the purposes of Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
(a)
foods and food ingredients containing, consisting of, or produced from soybean MON-877Ø8-9;
(b)
feed containing, consisting of, or produced from soybean MON-877Ø8-9;
(c)
soybean MON-877Ø8-9 in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

Labelling
Article 3
1. For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’.
2. The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of soybean MON-877Ø8-9 with the exception of products referred to in point (a) of Article 2.

Monitoring for environmental effects
Article 4
1. The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.
2. The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with Decision 2009/770/EC.

Community register
Article 5
The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder
Article 6
The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States of America.

Validity
Article 7
This Decision shall apply for a period of 10 years from the date of its notification.

Addressee
Article 8
This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, B-1150 Brussels — Belgium.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(1), and in particular Articles 7(3) and 19(3) thereof,
(1) On 2 February 2011, Monsanto Europe S.A. submitted to the competent authority of the Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from soybean MON87708 (‘the application’).
(2) The application also covers the placing on the market of soybean MON87708 in products consisting of it or containing it for any other uses than food and feed as any other soybean, with the exception of cultivation.
(3) In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 3 October 2013, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that soybean MON87708, as described in the application, is as safe as its non-genetically modified counterpart and reference varieties with respect to potential effects on human and animal health or the environment, in the context of its intended uses(3).
(5) In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of that Regulation.
(6) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(7) Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified soybean MON87708.
(8) A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(4).
(9) On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from soybean MON87708. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.
(10) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(5)lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(11) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(6). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.
(12) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(13) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(7).
(14) The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier

Genetically modified soybean (Glycine max(L.) Merr.) MON87708, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-877Ø8-9, as provided for in Regulation (EC) No 65/2004.

Authorisation

The following products are authorised for the purposes of Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
(a)
foods and food ingredients containing, consisting of, or produced from soybean MON-877Ø8-9;
(b)
feed containing, consisting of, or produced from soybean MON-877Ø8-9;
(c)
soybean MON-877Ø8-9 in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

Labelling

1. For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’.
2. The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of soybean MON-877Ø8-9 with the exception of products referred to in point (a) of Article 2.

Monitoring for environmental effects

1. The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.
2. The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with Decision 2009/770/EC.

Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder

The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States of America.

Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Addressee

This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, B-1150 Brussels — Belgium.

(a)   Applicant and Authorisation holder

ANNEX
Name | : | Monsanto Europe S.A.
Address | : | Avenue de Tervuren 270-272, B-1150 Brussels — BelgiumOn behalf of Monsanto Company — 800 N. Lindbergh Boulevard — St. Louis, Missouri 63167 — United States of America.
(b) Designation and specification of the products

(1) | foods and food ingredients containing, consisting of, or produced from soybean MON-877Ø8-9;
(2) | feed containing, consisting of, or produced from soybean MON-877Ø8-9;
(3) | soybean MON-877Ø8-9 in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.The genetically modified soybean MON-877Ø8-9, as described in the application, expresses the DMO (dicamba mono-oxygenase) proteins which confer tolerance to dicamba-based herbicides.
(c) Labelling

(1) | for the purposes of the specific labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’;
(2) | the words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of soybean MON-877Ø8-9 with the exception of products referred to in point (a) of Article 2.(d) Method for detection

— | event-specific real-time PCR based method for the quantification of soybean MON-877Ø8-9,
— | validated on genomic DNA, extracted from seeds, by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
— | Reference Material: AOCS 0311-A and AOCS 0906-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm(e) Unique identifier
MON-877Ø8-9
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity
Biosafety Clearing-House, Record ID: see [to be completed when notified].
(g) Conditions or restrictions on the placing on the market, use or handling of the products
Not required.
(h) Monitoring plan
Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
[Link:plan published on the internet]
(i) Post market monitoring requirements for the use of the food for human consumption
Not required.
Note:Links to relevant documents may need to be modified over the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.

Pending: 32015D0696

30.4.2015 EN Official Journal of the European Union L 112/60
(1) On 18 February 2010, Monsanto Europe SA submitted to the competent authority of The Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from soybean MON87705 (‘the application’).
(2) The application also covers the placing on the market of soybean MON87705 in products consisting of it or containing it for any other uses than food and feed as any other soybean, with the exception of cultivation.
(3) In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 30 October 2012, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003(3). It concluded that soybean MON87705, as described in the application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses as proposed by the applicant. These uses covered all food and feed uses as any conventional soybean except for the commercial frying uses of the oil.
(5) In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.
(6) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(7) Subsequently, the Commission mandated EFSA to complement its opinion to include commercial frying uses of the oil derived from MON87705, requesting the necessary information from the applicant, if needed.
(8) On 17 December 2013, EFSA issued a statement(4), complementing its initial opinion with the oil derived from MON87705 soybean for commercial frying and concluded that the updated nutritional assessment covering all food uses of soybean MON87705 oil does not impact on human health and nutrition.
(9) In addition to that, EFSA recommended in this complementing statement a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.
(10) Taking into account those considerations, authorisation should be granted to the products.
(11) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(5).
(12) Food, food ingredients and feed containing, consisting of, or produced from MON87705 soybean should be labelled in accordance with the requirements provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003.
(13) On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of MON87705 soybean and derived oil has been changed in relation to the conventional counterpart, a specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003.
(14) In order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.
(15) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(6)lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(16) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(7). The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.
(17) The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.
(18) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(19) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and point (c) of Article 15(2) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(8).
(20) The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
(a) foods and food ingredients containing, consisting of, or produced from MON-877Ø5-6 soybean;
(b) feed containing, consisting of, or produced from MON-877Ø5-6 soybean;
(c) MON-877Ø5-6 soybean in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.
Name : Monsanto Europe SA
Address : Avenue de Tervuren 270-272, 1150 Brussels, Belgium
1. foods and food ingredients containing, consisting of, or produced from MON-877Ø5-6 soybean;
2. feed containing, consisting of, or produced from MON-877Ø5-6 soybean;
3. MON-877Ø5-6 soybean in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.
1. For the purposes of the specific labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’.
2. For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.
3. The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of MON-877Ø5-6 soybean with the exception of products referred to in point (a) of Article 2.
1. Event-specific real-time PCR based method for the quantification of MON-877Ø5-6 soybean.
2. Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from soybean seeds, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
3. Reference Material: AOCS 0210-A and AOCS 0906-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
1. The authorisation holder shall collect the following information:(i)quantities of MON-877Ø5-6 soybean oil and MON-877Ø5-6 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food;(ii)in case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed. (i) quantities of MON-877Ø5-6 soybean oil and MON-877Ø5-6 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food; (ii) in case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.
(i) quantities of MON-877Ø5-6 soybean oil and MON-877Ø5-6 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food;
(ii) in case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.
(i) quantities of MON-877Ø5-6 soybean oil and MON-877Ø5-6 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food;
(ii) in case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.
2. The authorisation holder shall, based on the information collected and reported, review the nutritional assessment conducted as part of the risk assessment.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(1), and in particular Article 7(3) and Article 19(3) thereof,
(1) On 18 February 2010, Monsanto Europe SA submitted to the competent authority of The Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from soybean MON87705 (‘the application’).
(2) The application also covers the placing on the market of soybean MON87705 in products consisting of it or containing it for any other uses than food and feed as any other soybean, with the exception of cultivation.
(3) In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 30 October 2012, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003(3). It concluded that soybean MON87705, as described in the application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses as proposed by the applicant. These uses covered all food and feed uses as any conventional soybean except for the commercial frying uses of the oil.
(5) In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.
(6) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(7) Subsequently, the Commission mandated EFSA to complement its opinion to include commercial frying uses of the oil derived from MON87705, requesting the necessary information from the applicant, if needed.
(8) On 17 December 2013, EFSA issued a statement(4), complementing its initial opinion with the oil derived from MON87705 soybean for commercial frying and concluded that the updated nutritional assessment covering all food uses of soybean MON87705 oil does not impact on human health and nutrition.
(9) In addition to that, EFSA recommended in this complementing statement a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.
(10) Taking into account those considerations, authorisation should be granted to the products.
(11) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(5).
(12) Food, food ingredients and feed containing, consisting of, or produced from MON87705 soybean should be labelled in accordance with the requirements provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003.
(13) On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of MON87705 soybean and derived oil has been changed in relation to the conventional counterpart, a specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003.
(14) In order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.
(15) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(6)lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(16) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(7). The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.
(17) The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.
(18) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(19) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and point (c) of Article 15(2) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(8).
(20) The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier
Article 1
Genetically modified MON87705 soybean (Glycine max(L.) Merr.), as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-877Ø5-6, as provided for in Regulation (EC) No 65/2004.

Authorisation
Article 2
The following products are authorised for the purposes of Article 4(2) and Article 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
(a)
foods and food ingredients containing, consisting of, or produced from MON-877Ø5-6 soybean;
(b)
feed containing, consisting of, or produced from MON-877Ø5-6 soybean;
(c)
MON-877Ø5-6 soybean in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

Labelling
Article 3
1. For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’.
2. For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.
3. The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of MON-877Ø5-6 soybean with the exception of products referred to in point (a) of Article 2.

Monitoring for environmental effects
Article 4
1. The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.
2. The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with Decision 2009/770/EC.

Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003
Article 5
1. The authorisation holder shall ensure that the post-market monitoring plan of the MON-877Ø5-6 soybean oil, as set out in point (g) of the Annex, is put in place and implemented.
2. The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the post-market monitoring plan for the duration of the authorisation.

Community register
Article 6
The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder
Article 7
The authorisation holder shall be Monsanto Europe SA, Belgium, representing Monsanto Company, United States.

Validity
Article 8
This Decision shall apply for a period of 10 years from the date of its notification.

Addressee
Article 9
This Decision is addressed to Monsanto Europe SA, Avenue de Tervuren 270-272, 1150 Brussels, Belgium.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(1), and in particular Article 7(3) and Article 19(3) thereof,
(1) On 18 February 2010, Monsanto Europe SA submitted to the competent authority of The Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from soybean MON87705 (‘the application’).
(2) The application also covers the placing on the market of soybean MON87705 in products consisting of it or containing it for any other uses than food and feed as any other soybean, with the exception of cultivation.
(3) In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 30 October 2012, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003(3). It concluded that soybean MON87705, as described in the application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses as proposed by the applicant. These uses covered all food and feed uses as any conventional soybean except for the commercial frying uses of the oil.
(5) In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.
(6) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(7) Subsequently, the Commission mandated EFSA to complement its opinion to include commercial frying uses of the oil derived from MON87705, requesting the necessary information from the applicant, if needed.
(8) On 17 December 2013, EFSA issued a statement(4), complementing its initial opinion with the oil derived from MON87705 soybean for commercial frying and concluded that the updated nutritional assessment covering all food uses of soybean MON87705 oil does not impact on human health and nutrition.
(9) In addition to that, EFSA recommended in this complementing statement a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.
(10) Taking into account those considerations, authorisation should be granted to the products.
(11) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(5).
(12) Food, food ingredients and feed containing, consisting of, or produced from MON87705 soybean should be labelled in accordance with the requirements provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003.
(13) On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of MON87705 soybean and derived oil has been changed in relation to the conventional counterpart, a specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003.
(14) In order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.
(15) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(6)lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(16) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(7). The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.
(17) The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.
(18) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(19) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and point (c) of Article 15(2) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(8).
(20) The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier

Genetically modified MON87705 soybean (Glycine max(L.) Merr.), as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-877Ø5-6, as provided for in Regulation (EC) No 65/2004.

Authorisation

The following products are authorised for the purposes of Article 4(2) and Article 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
(a)
foods and food ingredients containing, consisting of, or produced from MON-877Ø5-6 soybean;
(b)
feed containing, consisting of, or produced from MON-877Ø5-6 soybean;
(c)
MON-877Ø5-6 soybean in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

Labelling

1. For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’.
2. For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.
3. The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of MON-877Ø5-6 soybean with the exception of products referred to in point (a) of Article 2.

Monitoring for environmental effects

1. The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.
2. The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with Decision 2009/770/EC.

Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003

1. The authorisation holder shall ensure that the post-market monitoring plan of the MON-877Ø5-6 soybean oil, as set out in point (g) of the Annex, is put in place and implemented.
2. The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the post-market monitoring plan for the duration of the authorisation.

Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder

The authorisation holder shall be Monsanto Europe SA, Belgium, representing Monsanto Company, United States.

Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Addressee

This Decision is addressed to Monsanto Europe SA, Avenue de Tervuren 270-272, 1150 Brussels, Belgium.

(a)   Applicant and authorisation holder:

ANNEX
Name | : | Monsanto Europe SA
Address | : | Avenue de Tervuren 270-272, 1150 Brussels, BelgiumOn behalf of Monsanto Company, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America.
(b) Designation and specification of the products:

1. | foods and food ingredients containing, consisting of, or produced from MON-877Ø5-6 soybean;
2. | feed containing, consisting of, or produced from MON-877Ø5-6 soybean;
3. | MON-877Ø5-6 soybean in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.The genetically modified MON-877Ø5-6 soybean, as described in the application, has a reduced expression of fatty acid Δ12-desaturase (FAD2) and palmitoyl acyl carrier protein thioesterase (FATB) enzymes, which results in increased oleic acid and reduced linoleic acid profile and expresses a CP4 EPSPS protein, which confers tolerance to glyphosate-based herbicides.
(c) Labelling:

1. | For the purposes of the specific labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’.
2. | For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.
3. | The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of MON-877Ø5-6 soybean with the exception of products referred to in point (a) of Article 2.(d) Method for detection:

1. | Event-specific real-time PCR based method for the quantification of MON-877Ø5-6 soybean.
2. | Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from soybean seeds, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
3. | Reference Material: AOCS 0210-A and AOCS 0906-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm(e) Unique identifier:
MON-877Ø5-6
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:
Biosafety Clearing-House, Record ID: see (to be completed when notified).
(g) Conditions or restrictions on the placing on the market, use or handling of the products:

Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003

1. | The authorisation holder shall collect the following information:(i)quantities of MON-877Ø5-6 soybean oil and MON-877Ø5-6 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food;(ii)in case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed. | (i) | quantities of MON-877Ø5-6 soybean oil and MON-877Ø5-6 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food; | (ii) | in case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.
(i) | quantities of MON-877Ø5-6 soybean oil and MON-877Ø5-6 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food;
(ii) | in case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.
2. | The authorisation holder shall, based on the information collected and reported, review the nutritional assessment conducted as part of the risk assessment.(h) Monitoring plan for environmental effects:
Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(Link:plan published on the internet)
Note:Links to relevant documents may need to be modified over the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.

Pending: 32015D0695

30.4.2015 EN Official Journal of the European Union L 112/56
(1) On 30 November 2004, Monsanto Europe S.A. submitted to the competent authority of the United Kingdom an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of food and feed cottonseed oil and its constituents produced from genetically modified cotton MON 531 x MON 1445.
(2) Food additives, feed materials and feed additives produced from genetically modified cotton MON 531 x MON 1445 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.
(3) On 17 April 2007, Monsanto Europe S.A. submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 531 x MON 1445 cotton.
(4) The scope of the two applications, taken together, covers the full range of current commercial uses of food and feed produced from cotton as defined in Articles 3(1)(c) and 15(1)(c) of Regulation (EC) No 1829/2003.
(5) On 28 March 2012, the European Food Safety Authority (‘EFSA’) gave a favourable opinion(2)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that products derived from genetically modified cotton MON 531 x MON 1445 are as safe as products derived from the conventional counterpart, in the context of their intended uses.
(6) EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 531 x MON 1445 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 531 x MON 1445.
(7) EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.
(8) Consequently, authorisation should be granted for the products produced from genetically modified cotton MON 531 x MON 1445.
(9) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(3).
(10) On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed produced from genetically modified cotton MON 531 x MON 1445.
(11) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(12) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(4).
(13) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
(a) food produced from MON-ØØ531-6 x MON-Ø1445-2 cotton;
(b) feed produced from MON-ØØ531-6 x MON-Ø1445-2 cotton.
Name : Monsanto Europe S.A.
Address : Avenue de Tervuren 270-272, B-1150 Brussels — Belgium
1. Food produced from MON-ØØ531-6 x MON-Ø1445-2 cotton.
2. Feed produced from MON-ØØ531-6 x MON-Ø1445-2 cotton.
1. Event specific real-time PCR based method for the quantification of MON-ØØ531-6 x MON-Ø1445-2 cotton
2. Validated on genomic DNA, extracted from seeds, by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
3. Reference Material: AOCS 0804-B, AOCS 0804-C and AOCS 0804-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(1), and in particular Articles 7(3), 11(3), 19(3) and 23(3) thereof,
(1) On 30 November 2004, Monsanto Europe S.A. submitted to the competent authority of the United Kingdom an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of food and feed cottonseed oil and its constituents produced from genetically modified cotton MON 531 x MON 1445.
(2) Food additives, feed materials and feed additives produced from genetically modified cotton MON 531 x MON 1445 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.
(3) On 17 April 2007, Monsanto Europe S.A. submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 531 x MON 1445 cotton.
(4) The scope of the two applications, taken together, covers the full range of current commercial uses of food and feed produced from cotton as defined in Articles 3(1)(c) and 15(1)(c) of Regulation (EC) No 1829/2003.
(5) On 28 March 2012, the European Food Safety Authority (‘EFSA’) gave a favourable opinion(2)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that products derived from genetically modified cotton MON 531 x MON 1445 are as safe as products derived from the conventional counterpart, in the context of their intended uses.
(6) EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 531 x MON 1445 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 531 x MON 1445.
(7) EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.
(8) Consequently, authorisation should be granted for the products produced from genetically modified cotton MON 531 x MON 1445.
(9) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(3).
(10) On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed produced from genetically modified cotton MON 531 x MON 1445.
(11) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(12) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(4).
(13) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier
Article 1
Genetically modified cotton (Gossypium hirsutumL. andGossypium barbadenseL.) MON 531 x MON 1445, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØ531-6 x MON-Ø1445-2, as provided for in Regulation (EC) No 65/2004.

Authorisation
Article 2
The following products are authorised for the purposes of Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
(a)
food produced from MON-ØØ531-6 x MON-Ø1445-2 cotton;
(b)
feed produced from MON-ØØ531-6 x MON-Ø1445-2 cotton.

Labelling
Article 3
For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, the ‘name of the organism’ shall be ‘cotton’.

Community register
Article 4
The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder
Article 5
The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States of America.

Validity
Article 6
This Decision shall apply for a period of 10 years from the date of its notification.

Addressee
Article 7
This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, B-1150 Brussels — Belgium.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(1), and in particular Articles 7(3), 11(3), 19(3) and 23(3) thereof,
(1) On 30 November 2004, Monsanto Europe S.A. submitted to the competent authority of the United Kingdom an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of food and feed cottonseed oil and its constituents produced from genetically modified cotton MON 531 x MON 1445.
(2) Food additives, feed materials and feed additives produced from genetically modified cotton MON 531 x MON 1445 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.
(3) On 17 April 2007, Monsanto Europe S.A. submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 531 x MON 1445 cotton.
(4) The scope of the two applications, taken together, covers the full range of current commercial uses of food and feed produced from cotton as defined in Articles 3(1)(c) and 15(1)(c) of Regulation (EC) No 1829/2003.
(5) On 28 March 2012, the European Food Safety Authority (‘EFSA’) gave a favourable opinion(2)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that products derived from genetically modified cotton MON 531 x MON 1445 are as safe as products derived from the conventional counterpart, in the context of their intended uses.
(6) EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 531 x MON 1445 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 531 x MON 1445.
(7) EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.
(8) Consequently, authorisation should be granted for the products produced from genetically modified cotton MON 531 x MON 1445.
(9) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(3).
(10) On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed produced from genetically modified cotton MON 531 x MON 1445.
(11) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(12) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(4).
(13) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier

Genetically modified cotton (Gossypium hirsutumL. andGossypium barbadenseL.) MON 531 x MON 1445, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØ531-6 x MON-Ø1445-2, as provided for in Regulation (EC) No 65/2004.

Authorisation

The following products are authorised for the purposes of Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
(a)
food produced from MON-ØØ531-6 x MON-Ø1445-2 cotton;
(b)
feed produced from MON-ØØ531-6 x MON-Ø1445-2 cotton.

Labelling

For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, the ‘name of the organism’ shall be ‘cotton’.

Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder

The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States of America.

Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Addressee

This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, B-1150 Brussels — Belgium.

(a)   Applicant and Authorisation holder

ANNEX
Name | : | Monsanto Europe S.A.
Address | : | Avenue de Tervuren 270-272, B-1150 Brussels — BelgiumOn behalf of Monsanto Company — 800 N. Lindbergh Boulevard — St. Louis, Missouri 63167 — United States of America.
(b) Designation and specification of the products

1. | Food produced from MON-ØØ531-6 x MON-Ø1445-2 cotton.
2. | Feed produced from MON-ØØ531-6 x MON-Ø1445-2 cotton.The genetically modified MON-ØØ531-6 x MON-Ø1445-2 cotton, as described in the application, expresses the Cry1Ac protein which confers resistance to lepidopteran pests and the CP4 EPSPS protein which confers tolerance to glyphosate-containing herbicides. AnnptII gene, conferring kanamycin and neomycin resistance, andaadA gene, conferring spectinomycin and streptomycin resistance, were used as selective markers in the genetic modification process.
(c) Labelling
For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, the ‘name of the organism’ shall be ‘cotton’.
(d) Method for detection

1. | Event specific real-time PCR based method for the quantification of MON-ØØ531-6 x MON-Ø1445-2 cotton
2. | Validated on genomic DNA, extracted from seeds, by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
3. | Reference Material: AOCS 0804-B, AOCS 0804-C and AOCS 0804-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm(e) Unique identifier
MON-ØØ531-6 x MON-Ø1445-2
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity
Not applicable.
(g) Conditions or restrictions on the placing on the market, use or handling of the products
Not required.
(h) Monitoring plan for environmental effects
Not required.
(i) Post-market monitoring requirements for the use of the food for human consumption
Not required.